Diagnostics systems and methods

ABSTRACT

A diagnostic system that includes a cartridge and a reader is discussed herein. The cartridge can contain a patient sample, such as a blood sample. The cartridge is inserted into the reader and the patient sample is analyzed. The reader contains various analysis systems, such as an electrophoresis detection system that uses electrophoresis testing to identify and quantify various components of the blood sample. The reader can process data from the various patient sample analysis to provide interpretative results indicative of a disorder, condition, disease, or infection of the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application also claims the benefit of U.S. Provisional PatentApplication Ser. No. 62/866,554, filed Jun. 25, 2019, and the benefit ofU.S. Provisional Patent Application Ser. No. 62/987,237, filed Mar. 9,2020. The contents of which are herein incorporated by reference intheir entirety.

BACKGROUND

Patient diagnostic services save lives, reduce the time to treatment forthe patient and provide valuable insight for targeted treatment. In manydeveloped countries, modern medical facilities can provide patients withthe most advanced diagnostic services allowing patients to beefficiently and effectively treated. In less developed countries orregions, high quality medical facilities and diagnostic services can belacking, often due to economic and infrastructure considerations. Inmany less developed countries, the economy cannot afford the latest inmedical technology and infrastructure, such as a robust power grid orhighly trained clinicians, required to support the high demands ofmodern medical technology. Sadly, a large portion of the world'spopulation resides in underserved or developed areas where the lack ofefficient and effective diagnostic services critically impacts thepopulation morbidity, mortality and overall health. This lack of medicalcare can lead or contribute to knock-on effects, such as low economicand educational development.

Often, many less developed countries and areas also lack sufficienttrained users that are typically required to perform the necessarydiagnostic services. This can lead to inconclusive or erroneous resultsfrom diagnostic services or to significant delays in diagnosis as thediagnostic services are required to be performed in another locationthat has the requisite infrastructure, knowledge, or both to perform thediagnostic service. For patients, this can mean further delays intreatment, which can decrease their chances of survival, increase thespread of the disease, lead to increased debilitation caused by thedisease or condition, the like or combinations or multiples thereof.

Where large laboratories may be prohibitively expensive and difficult tostaff, diagnostic devices may provide an effective solution. Such asolution could provide timely, accurate, and cost-effective health care.

One of the treatable common ailments effecting less developed countriesare hemoglobin disorders, such as sickle cell disease (SCD), thalassemiaand other hemoglobinopathies. These are genetic disorders that arebelieved to have evolved in response to malaria. With populationmigration, these conditions have spread to the global population andaffect the livelihood and health of a large number of people. With earlydetection or diagnosis, these conditions can be treated and managed tominimize any adverse impact on the stricken individual. As with malaria,these disorders affect the populations of less developed countries andareas, which have limited to no access to the diagnostic services torapidly, effectively and efficiently diagnose the conditions.

What is needed is a device or system to efficiently and effectivelydiagnose a disease, condition, or ailment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an example diagnostic system.

FIGS. 2A-2B illustrate example cartridges.

FIGS. 3A-3B illustrate an example electrophoresis detection system.

FIG. 3C illustrates an example electrophoresis detection system.

FIG. 4 illustrates an example analysis method using the exampleelectrophoresis detection system shown in FIGS. 3A-3B.

FIG. 5 is a block diagram of an example diagnostic system.

FIG. 6 is a block diagram of another example cartridge.

FIG. 7 illustrates an example patient sample analysis process.

FIG. 8 is yet another example cartridge and electrophoresis detectioncomponents.

FIG. 9 illustrates a further example diagnostic system.

FIG. 10 is an example reader network.

DETAILED DESCRIPTION

Various example in vitro diagnostic devices and methods for detectingand helping to diagnose blood disorders, and specifically inheritedblood disorders or other conditions or diseases, are described herein.The disclosed diagnostic devices include a cartridge and a reader thatinterface to analyze a patient biologic sample, such as a blood sample,or another non-human biologic sample or a non-biologic sample, toprovide a diagnosis, or data regarding one or more disorders, diseases,or conditions of the patient, patient can be human of animal, ornon-biologic sample. For simplicity. The sample will be referred to as abiologic sample but non-biologic samples are also included. Thecartridge can contain or support the biologic sample for analysis by oneor more diagnostic systems of the reader. An electrophoresis system, invitro diagnostic system, or patient biologic sample analysis systems,such as a magneto-optical system, can be included in the reader andcartridge to diagnose, provide, or diagnose and provide patient biologicsample data regarding a variety of diseases or conditions. The cartridgeand reader provide an economic, efficient, and effective diagnosticsystem. The biologic sample could be the patient's blood, saliva, urine,other fluid, a liquid suspension of tissue, a combination of fluids orother biologic component. Several of the examples discussed hereinexplain the systems and methods of analyzing a patient blood sample, butit is understood that any biologic sample could be used. Additionally,the electrophoresis systems described herein can also be used to analyzeother, non-biologic, liquids, compounds, the like, or combinations ormultiples thereof using the electrophoresis analysis method.

In the following descriptions, the term “analyte” is used to describe amaterial of interest within the sample. It should also be understoodthat the analyte can be a fraction of a sample (e.g., plasma, buffycoat, or red blood cells) or a component of a sample (a cell, such asova, fetal material (such as trophoblasts, nucleated red blood cells,fetal red blood cells, fetal white blood cells, fetal DNA, fetal RNA, orthe like), a circulating tumor cell (“CTC”), a circulating endothelialcell, an immune cell (i.e. naïve or memory B cells or naïve or memory Tcells), a mesenchymal cell, a stem cell, a vesicle, such as an exosome,a liposome, a protein, a nucleic acid, a biological molecule, anaturally occurring or artificially prepared microscopic unit having anenclosed membrane, parasites (e.g. spirochetes; malaria-inducing agents,such as Plasmodium), microorganisms, viruses, or inflammatory cells.

FIG. 1 illustrates an example reader 110 and cartridge 120 of adiagnostic system 100. A diagnostic system includes devices that arephysically located at the site at which patients are tested andsometimes treated to provide quick results and highly effectivetreatment. The devices can provide information and help in diagnosingpatient disorders, infections, or both while the patient is present withpotentially immediate referral, treatment, or both. Unlike gold standardlaboratory-based blood testing for disorders, infections, or both, thedisclosed devices enable diagnosis close to the patient whilemaintaining high sensitivity and accuracy aiding efficient and effectiveearly treatment of the disorder, infection, or both. The diagnosticsystem 100 can be used in a traditional lab setting, in the field (i.e.,point-of-care), or the like.

The reader 110 includes a housing 112, a cartridge receptacle 114 and adisplay 116. The cartridge 120, which contains the patient sample and,optionally dilutents, markers, reagents materials, the like, orcombinations or multiples thereof is inserted into the cartridgereceptacle 114 of the reader 110 to transfer the patient sample, treatedor untreated, into the reader 110 to perform a diagnostic test oranalysis. The cartridge 120 more generally is placed in proximity to thereader in such a manner that the reader can interact with one or moreelements of the cartridge to perform analysis of the patient sample. Thecartridge 120 can include a pipette-like end 122 and a bulb 124 forsiphoning a patient sample into the cartridge 120 in preparation for thediagnostic test. Alternatively, the cartridge 120 can include acapillary tube by which the patient sample can be obtained for analysis,testing, or both. In a further embodiment, collection of the patientblood sample can be performed using blotting paper that is included inthe cartridge 120 to collect a blood spot that can be analyzed by thediagnostic system 100.

The housing 112 of the reader 110 can be constructed of materials suchas plastic or metal and is preferably sealed with a smooth surface,which allows the reader 110 to be easily cleaned or disinfected andresist external water and or dust. Further, the housing 112 issufficiently strong to allow the safe transport and use of the reader110 without substantial damage to the reader 110 and the diagnosticsystems within. Additionally, the housing 112 can have properties thatshield or minimize the exposure of the interior of the reader 110 totemperature, humidity, or both, variations, light intrusion, or both.The robustness of the reader 110 allows it to be used in a variety oflocations and environments without adversely affecting the results ofthe diagnostic system.

The housing 112 of the reader 110 can also include vibration isolationto minimize vibration of the reader 110 during the measurement processto assist with preventing analysis error of the patient sample.Vibration isolation can include suspending or isolating the componentsor systems of the reader 110 within the housing 112 or containing thecomponents or systems within an internal housing that is suspended orisolated from the external housing 112. Alternative vibration isolationcan include anti-vibration feet or mounts on which the reader 110 cansit on a surface. Additional vibration isolation can include placing thereader 110 on a cushioned or anti-vibration mat to reduce or limit thevibration or disturbance of the reader 110 by its external environment.

The cartridge receptacle 114 can be conformably shaped to receive thecartridge 120. The cartridge 120 can be received partially or completelyinto the cartridge receptacle 114 or the reader 110. Alternatively, thecartridge 120 can be otherwise connected, such as by an externalreceptacle or conduit, to the reader 110 to transfer the patient sample,or portion thereof, into the reader 110. Such an external receptacle orconduit can be electrically coupled to the electronics housed in thereader 110 by a wireless or hard-wire connection of any suitableconfiguration.

FIGS. 2A-2B illustrate example cartridges 200 a and 200 b. Each of theexample cartridges 200 a, 200 b include a housing 202 a, 202 b an upperportion 210 a, 210 b and a lower portion 230 a, 230 b. The cartridges200 a, 200 b can include a sample chamber, such as 240 of FIG. 2A, thatis internal to the cartridge 200 a, 200 b and can store a patientsample, such as a blood sample, within the cartridge 200 a, 200 b. Thecartridges 200 a, 200 b transport or store a patient sample foranalysis, or reading, by a reader. Further, the cartridges 200 a, 200 bcan interface with the reader to assist with or facilitate the readingor analysis of the patient sample stored within the cartridge 200 a, 200b. That is, the cartridge 200 a, 200 b can include features, such as anoptical window 220 and an electrophoresis element 250 of cartridge 200 bof FIG. 2B to assist with the analysis of the patient sample within thecartridge 200 a, 200 b. The cartridge 200 a, 200 b can also transfer allor a portion of the patient sample to the reader for analysis of thepatient sample. The patient sample, or portion thereof, from thecartridge 200 a, 200 b can be transferred to a blood sample chamber ofthe reader or to another location of the reader, or external from thereader, for analysis of the patient blood sample.

The cartridges 200 a, 200 b can be specific to a condition, disease,ailment, the like, or combinations or multiples thereof. The cartridges200 a, 200 b can include various features, external, internal, or both,that customize a particular cartridge for the analysis of a specific,singular or multiple, condition, disease, ailment, the like, orcombinations or multiples thereof. The cartridge specificity can includethe patient sample size volume of the cartridge, various dilutents,markers, reagents conditions, disorders, diseases, ailments, the like,or combinations or multiples thereof in the cartridge, the interface ofthe cartridge with the reader and other design or constructionspecification of the cartridge in relation to one or more particularconditions, diseases, ailments, the like, or combinations or multiplesthereof.

The housing 202 a, 202 b of the cartridge 200 a, 200 b can includestructural, material, geometric features, the like, or combinations ormultiples thereof that assist or facilitate the analysis or acquisitionof the patient sample. Such features can include internal chambers, suchas the sample chamber 240 of FIG. 2A, to store the patient sample orother fluids or compounds, that are sized to ensure adequate sample sizefor the analysis of the collected patient blood sample, interfaces thatinteract with, engage, or facilitate the systems of the reader duringanalysis of the patient sample. Other features can include environmentalcontrols that maintain the collected patient sample in a suitablecondition for analysis, and other features or considerations. Forexample, an internal chamber of the reader could manually orautomatically interface with the inserted cartridge via a port to causedilutents, markers, other chemical treatments, the like, or combinationsor multiples thereof to mix with the patient sample in the cartridge.Such a port would be a passage, like a tube, that connects the samplechamber of the cartridge with the port so fluids can be added to thecartridge. The addition of such external fluids can be triggeredmanually when a user actuates a switch or other actuator, which the usermay do in response to a user prompt to do so. The cartridge housing 202a, 202 b can be formed of a suitable material such as a plastic,composite, metal, the like, or combinations or multiples thereof tocreate a robust, disposable cartridge 200 a, 200 b. Additionally, thehousing 202 a, 202 b material can be selected for the ability to besterilized, such as sterilizing the cartridge 200 a, 200 b prior to use,for reuse or for killing pathogens prior to disposal.

Environmental considerations can also be used in the determination of asuitable material(s) for the cartridge housing 202 a, 202 b. Suchenvironmental considerations can include the biodegradability of thehousing material, the recyclability of the housing material, theincineration by-products of the housing material and other environmentalconsiderations. These environmental considerations can reduce theenvironmental impact of the disposal, recycling, reuse, the like, orcombinations or multiples thereof of the cartridges 200 a, 200 b afteruse.

The housing 202 a, 202 b of the cartridge 200 a, 200 b can include apatient identification marker or an area to apply or mark patientidentification onto the cartridge 200 a, 200 b. This marker could be inmachine readable or human readable form or both. The patientidentification allows the correlation of the analysis of the collectedpatient sample with a particular patient.

Additionally, the reader can detect the patient identification marker tocorrelate the analysis with a patient, including automatically appendingthe analysis results to a patient's medical records. In an exampleembodiment, the patient identification can be obfuscated to removepatient personal information, such as a name, from the cartridge 200 a,200 b, instead the patient can be assigned a random number, or sequenceof characters, that is correlated to the particular patient in thereader, a computer or other system.

Patient diagnostic and demographic information can also be used foranalysis to determine trends or emergence of conditions, disorders,diseases, ailments, the like, or combinations or multiples thereof. Thisanalysis can be used to prevent or minimize the spread of the conditionor disorder, targeted diagnosis, treatment of the condition or disorderconditions, disorders, diseases, ailments, the like, or combinations ormultiples thereof. For various conditions once properly diagnosed, suchas a sickle cell and other hemoglobin conditions, geographicalcorrelation of the prevalence of the condition can be used to performmeasures to mitigate and minimize the effects of the condition on thetarget population.

The upper portion 210 a, 210 b of the cartridge 200 a, 200 b can includeidentification marker(s), such as a color, pattern, name, or otherdistinguishing features. The identification marker can be used toindicate the use of the cartridge 200 a, 200 b for the analysis of aspecific condition(s), disease(s), ailment(s) conditions, disorders,diseases, ailments, the like, or combinations or multiples thereof. Thiscan provide a clear, visual indication to a user that the cartridge 200a, 200 b is to be used with specific analysis or analyses.

Additionally, the upper portion 210 a, 210 b can be a portion of asample collection element, such as a suction bulb, actuation element, orcapillary tube to assist or facilitate the collection of the patientsample into the cartridge 200 a, 200 b. As a suction bulb, the upperportion can be formed of a resilient or flexible material capable ofdeforming in volume to assist in the uptake of a patient sample withinthe cartridge 200 a, 200 b. As an actuation element, the application ofpressure or other input by a user, other or device to the upper portion210 a, 210 b of the cartridge 200 a, 200 b can actuate the passive oractive acquisition of a patient sample into the cartridge 200 a, 200 bin preparation for analysis, such as extending, retracting, or both, aneedle or capillary tube. A capillary tube is one means of passivelycollecting the sample with no user or machine pressure required.

Further, the upper portion 210 a, 210 b can contain a dilutent, marker,reagent or other fluid or substance that is stored internally in achamber and that can be released into, mixed with, or both, the patientsample within the cartridge 200 a, 200 b. Application of pressure to theupper portion 210 a, 210 b of the cartridge 200 a, 200 b can introducethe contained substance or fluid into the patient sample within thecartridge 200 a, 200 b which mixes the patient sample with the containedsubstance(s) or fluid(s). Example dilutent ratios can include from 1:0.5to 1:100. The contained substance or fluid can assist with the analysisof the patient sample, preparation of the patient sample for analysis,preservation of the sample for analysis or other desirable or necessarypatient sample modification for efficient and effective analysis of thepatient sample.

Additionally, the upper portion 210 a, 210 b of the cartridge 200 a, 200b can be contoured or shaped to provide a comfortable, ergonomic, oreasy grip for a user to handle the cartridge 200 a, 200 b duringinsertion into or extraction from the reader or diagnostic device.Alternatively, the surface texture of the upper portion 210 a, 210 b canbe such that it improves the ability of a user to grip the cartridge 200a, 200 b.

The optical window 220 can be included on the cartridge 200 a, 200 b,which allows light to pass into, through, or both, a portion of thecartridge 200 a, 200 b such as a sample chamber containing the patientsample, such as 240 of FIG. 2A. The ability to pass light into, through,or both, the sample volume within the cartridge 200 a, 200 b can be anecessary step during analysis of the patient sample within thecartridge 200 a, 200 b. The optical window 220 can be a material,construction, or both, that necessarily or desirably alters lightentering the optical window 220 as a part of the analysis of the patientsample within, such as collimating, filtering, polarizing conditions,disorders, diseases, ailments, the like, or combinations or multiplesthereof the light that passes through the optical window 220.Alternatively, the optical window 220 can be transparent or translucent,or can be an opening within the housing 202 a, 202 b of the cartridge200 a, 200 b. The cartridge 200 a, 200 b can include a reflectoropposite the optical window 220, 220 b that reflects the incoming lightback through the optical window 220 a, 220 b or through another opticalwindow, or can include a further optical window opposite the light entrywindow to allow light to pass through the cartridge 200 a, 200 b.

An electrophoresis element, such as 250 of cartridge 200 b of FIG. 2B,can assist with performing an electrophoresis analysis of a patientsample within the cartridge 250. The electrophoresis element 250 caninclude electrodes to establish an electrical gradient across theelement to perform the electrophoresis analysis. A cover can be includedto protect the electrophoresis element, while still allowing the resultsto be viewed either through the cover or by removal of the cover. Thecover can be optically transparent to allow optical viewing of theresults or the electrophoresis process being performed. Light can bereflected off of, transmitted through, absorbed by, or combinationsthereof the electrophoresis element 250 to assist with viewing theresults displayed thereon. The cartridge 200 b can include one or morestructural features to facilitate the transmission of light through theelectrophoresis element 250.

The lower portion 230 a, 230 b can house or be a portion of the samplecollection system. In the examples shown in FIGS. 2A and 2B, the lowerportion 230 a, 230 b can include a channel or tube through which thepatient sample can be transferred into the interior of the cartridge 200a, 200 b. The lower portion 230 a, 230 b can also house a portion of thesample collection system, such as an extendable needle like a lancet ora capillary tube through which the patient sample can be transferred tothe interior of the cartridge 200 a, 200 b.

The lower portion 230 a, 230 b can also include elements or systems toassist with the analyzing, storage, or both, of the patient sample. Thiscan include an interface or mechanism to release at least a portion ofthe patient sample from within the cartridge 200 a, 200 b into thereader, a barrier, a seal, or the like that restrains or preserves thepatient sample within the cartridge 200 a, 200 b.

The lower portion 230 a, 230 b can further include an indicator that isvisible once the cartridge 200 a, 200 b has been previously used. Thiscan prevent cross-contamination of patient specimens or prevent thereuse of a single-use cartridge 200 a, 200 b which could alter orotherwise compromise the results of the patient sample analysis. Theindication can be structural in nature, with an alteration, such as aremoval or break in a portion of the cartridge 200 a, 200 b housing 202a, 202 b of the lower portion 230 a, 230 b that is a visible once thecartridge 200 a, 200 b has been used or has acquired a patient sample.Additionally, the lower portion 230 a, 230 b can deform afteracquisition of a patient sample within the cartridge 200 a, 200 b, whichprevents further collection of a patient sample(s) using the cartridge200 a, 200 b. The indication could be electrical.

FIGS. 3A-3B illustrate an example electrophoresis detection system 300.The electrophoresis detection system 300 includes an electrophoresisstrip 302, electrodes 304, 306, patient sample 310 and an opticalimaging device 330. The electrophoresis analysis of a patient sample 310can be used to evaluate aspects of the patient sample 310 that areeffected due to an applied electric potential or voltage. Aspects of thepatient sample 310 that can be affected by an electric potential caninclude proteins, such as hemoglobin, due to its charge. Varioushemoglobin disorders can be diagnosed, evaluated, monitored conditions,disorders, diseases, ailments, the like, or combinations or multiplesthereof using the electrophoresis testing, including determining therelative proportions of the hemoglobin types of the patient sample 310.Results of the electrophoresis analysis can be optically captured byimaging. A light source, not shown, can be used to assist the capture ofthe results, with the light source emitting light that is thenreflected, absorbed by, or transmitted through the electrophoresis strip302 to assist with imaging, recording, or visualizing theelectrophoresis results thereon.

FIG. 3A illustrates the initial set-up of the electrophoresis process.The electrophoresis strip 302 can have a buffer solution depositedthereon to assist with establishing the electrical conductivity betweenthe two electrodes 304 and 306. A patient sample 310, such as a bloodsample, is placed on the electrophoresis strip 302 in a controlledmanner. In the example shown in FIG. 3A, the patient sample 310 is showndeposited as a line, the more precise or controlled the sample isdeposited onto the electrophoresis strip 302 the more clearly thebanding can be visualized. Additionally, the patient sample 310 caninclude added compounds or components, such as one or more markers. Theadded compounds or components can assist with the electrophoresisprocess or assist with interpreting the electrophoresis results.

For example, the one or more markers can have known migrations rates,distances, or both, for a given applied voltage, voltage applicationtime, or both. Alternatively, these markers can normalize the results ofthe electrophoresis process by having migration rates relative to thesample, thereby reducing the effects of sample-to-sample variability.These markers can assist with evaluating the resultant banding of thepatient sample 310. With the patient sample 310 in place, a voltage isapplied using the electrodes 304 and 306, causing various components ofthe patient sample 310 to migrate across the electrophoresis strip inthe direction indicated by arrow 308 over a defined time. The variouscomponents of the patient sample 310 will separate into bands due to theapplied voltage and the physical and electrical properties of thevarious components. One or all of the applied voltage, current and theapplication time can be predetermined or preset based on the variousparameters of the electrophoresis testing being performed.Alternatively, one or more of the voltage, current and application timescan be variable and based on the banding of the patient sample or anadded compound or component therein. For example, the movement of amarker added to the patient sample 310 can be monitored as the markermoves across the electrophoresis strip 310. That is, imaging ormonitoring of the electrophoresis testing, the markers thereon, or both,can be performed in a continuous or timed interval manner during thetesting process. For example, images of the electrophoresis process canbe continuously captured, such as by a video imaging process, or theimages can be captured at regular intervals based on time, the distance,or both, one or more bands have traveled. Once the marker has reached apredetermined location across the electrophoresis strip 302, the testcan be terminated with the removal of the applied voltage.

FIG. 3B illustrates the completed electrophoresis process. Afterapplying a voltage, via electrodes 304 and 306, for an amount of time,the patient sample 310 has separated into the various bands, 312, 314,316 and 318, which have moved from an initial patient sample location311. Additionally, added markers 320 a and 320 b have separated from theinitial patient sample 310 and have moved along the length of theelectrophoresis strip 302. The intensity, location, other band detectioncharacteristics conditions, disorders, diseases, ailments, the like, orcombinations or multiples thereof of the various bands 312, 314, 316 and318 can be used to identify the components, and their relativeproportions, of the initial patient sample 310. The optical imagingdevice 330 can image the electrophoresis strip 302, during, after, orboth, the electrophoresis process, for processing to identify thecompounds represented by the various bands 312, 314, 316 and 318 andtheir relative proportions.

The optical imaging device 330 can acquire a set of images or video atan adjustable frame rate, or frames per second (FPS). In one example,the frame rate can be 1 FPS. In another example, the frame rate can begreater than 1 FPS, including at least 10 FPS, 24 FPS, 30 FPS, 120 FPS,240 FPS, 1000 FPS, 5000 FPS, 10000 FPS, or the like.

The optical imaging device 330 can capture images or video with highdynamic range (HDR) to provide enhanced image or video quality. Theimages or video can be taken at various exposures, at different f-stops,at different ISO settings, at different wavelengths, the like, orcombinations or multiples thereof. In one example, a first image can becaptured where an emission from the sample is at 375-440 nm, including415 nm, and a second image can be captured where an emission from thesample is at 525 nm. The different wavelengths can be acquired acrossdifferent images by using one or more filters, one or more lightsources, the like, or combinations or multiples thereof. As anotherexample, the settings of the optical imaging device 330 can be adjustedbetween images or over the duration of the video.

The electrophoresis detection system 300 can be used to identify andmonitor hemoglobin disorders, such as sickle cell disease (SCD) andthalassemia. For SCD, monitoring the various hemoglobin types and theirproportions is an important part of patient treatment. SCD patientsproduce sickle hemoglobin (HbS), resulting in malformed red blood cellsthat have reduced oxygen carrying capacity and present other patientissues due to their malformed shape and properties. The treatment forSCD patients is often blood transfusions, which increases the proportionof normal adult hemoglobin (HbA) for the patient and hydroxyurea whichstimulates the formation of fetal hemoglobin (HbF). A patient'shemoglobin levels can be monitored to determine the efficacy of thetreatment regime and to properly time the administration of varioustherapies. Using the disclosed electrophoresis systems and methodsdisclosed herein, levels of the various hemoglobin types of a patientcan be monitored to more accurately and effectively treat hemoglobindisorders.

Imaging of the patient sample 310, bands 312-318, or both can beperformed at one or more wavelengths. An illumination source, such as alight box, can include one or more light sources (e.g., light emittingdiodes). When the illumination source includes multiple light sources,each light source emits a stimulus, such as light, at a differentwavelength. Each stimulus causes the patient sample to generate a bandcharacteristic. For example, the illumination source emits a firststimulus having a first wavelength to generate a first bandcharacteristic of the patient sample. The illumination source emits asecond stimulus having a second wavelength to generate a second bandcharacteristic of the patient sample. The first and second wavelengthsare different. Band detection data based on the first and second bandcharacteristics can be used to identify a component, a protein type, aprotein variant or sub-species, or the like of the patient sample. Theidentified component, protein type, protein variant, proteinsub-species, or the like can be output. Furthermore, diagnostic resultscan be generated and output based on band detection data, the componenttype, the protein type, the like, or combinations or multiples thereof.

Each light source can be controlled by individual intensities, includingwhen multiple light sources are used simultaneously. A channel is awavelength range of an electromagnetic spectrum. For example, a firstlight emitting diode (LED) can emit light in a red channel, a second LEDcan emit light in a green channel, and a third LED can emit light in theUV channel. The LEDs can be used alone or together. The illuminationsource can include up to 5 light sources, up to 10 light sources, ormore. Alternatively, the illumination source can emit up to 5wavelengths, up to 10 wavelengths, or more, such as by a light box.Alternatively, a single light source, such as white light, could befiltered to only emit a single or multiple pre-determined wavelengths.

The wavelengths of the stimuli emitted by the illumination source can beselected based on peak absorption of the compound or analyte of interestor on peak absorption of a dye or stain conjugated to the compound oranalyte of interest. For example, in one sample, Hb A can have peakabsorption at a first wavelength and Hb A2 can have peak absorption at asecond wavelength. The illumination source can emit a first wavelengthat the peak absorption of the first stain and a second wavelength at thepeak absorption of the second stain.

As another example, for hemoglobin variant electrophoresis (i.e., Hb Aand Hb A2), a wavelength in the UV spectrum can be used. A wavelength inan area of high absorption of hemoglobin can be used, such as 415 nm, toincrease the detection limit.

The wavelengths emitted by the illumination source can be selected basedon fluoresces of the compound or analyte of interest or on fluoresces ofa dye or stain conjugated to the compound or analyte of interest. Forexample, in one sample, a hemoglobin A variant (Hb A) can be labeledwith a first stain and a hemoglobin A2 variant (Hb A2) can be labeledwith a second stain. The illumination source can emit wavelengths tocause the stains to fluoresce. As another example, Hb A can havefluoresces at a first wavelength and Hb A2 can have fluoresces at asecond wavelength. The illumination source can emit wavelengths to causethe stains to fluoresce.

As another example for fluorescence, the patient sample 310, bands312-318, stains conjugated to the sample or bands, or combinationsthereof can be excited at one or more wavelengths and then imaged atother wavelengths that correspond to the wavelength of fluorescence. Inother words, an excitation light having a first wavelength is used tostimulate the sample, band, or stain and the sample, band, or stainemits an emission light having a second wavelength. The secondwavelength can be greater than the first wavelength due to a Stoke'sshift.

In one example, a filter can be located in an optical path from thepatient sample to the detector. The filter can be used to remove orfilter out the illuminating light, so that only light emitted by thestains or bands is transmitted to and captured by the detector. Thefilter might be external to the camera or contained within the camera.

During electrophoresis, as shown in FIG. 3C, more volume of the patientsample 310 can be added, such as with an applicator. The applicator canadd a patient sample 322 having more volume than patient sample 310. Theadditional volume of the patient sample 322 provides a higherconcentration of the compound or analyte of interest, which can allowfor enhanced detection as the band for the compound or analyte ofinterest is wider. For example, for hemoglobin, a higher percent

A control can also be included in the electrophoresis process. Thecontrol can be added to the electrophoresis strip 302, the patientsample 310, or the like. The control has a known size such that thelocation of the control during or after electrophoresis or the speedduring electrophoresis can provide a standard against which othercomponents can be compared. The control can be used to normalize speedof other components during electrophoresis. The control can aid indetermining total hemoglobin as a relative measurement or an absolutemeasurement.

For example, Hb A has a molecular size of 16 kiloDaltons (kDa) and Hb A2has a molecular size of 19.5 kDa. A control can have a molecular size of17.75 kDa, such that the control falls between the Hb A and Hb A2 duringelectrophoresis to determine which bands correlate to which variant orcontrol. The control can also be greater than Hb A or less than Hb A2 bya given amount. Knowing the size and end location can be used todetermine where the Hb and Hb A2 variants are located, such as by theladder method (i.e., determining band spacing or band width andcomparing those against known locations).

FIG. 4 is an example analysis method 400 The analysis of a patientsample, which is patient blood in this example, is performed todetermine a blood characteristic, which can include the presence of adisease or condition, quantification of a disease or condition,likelihood of the presence of a disease or condition, a characteristicthat can be indicative of a disease or condition, a quantification of acharacteristic that can be indicative of a disease or condition, otherblood characteristic conditions, disorders, diseases, ailments, thelike, or combinations or multiples thereof that can be effected by thepresence of a disease or condition of the patient. The example method ofFIG. 4 can be performed using a reader and cartridge system, such as theexample shown in FIG. 1 . The reader can include one or more systems orelements to analyze, quantify, identify or otherwise determinecharacteristics of a patient sample that can be indicative of thepresence of a disease, condition, infection, or the like of the patient.

An initial step 402 of the method 400 can include the collection of apatient sample for analysis, in this example, a blood sample.Alternative patient samples, such as saliva, tissue, or other bodilyfluids and also non-biological samples can be collected for analysis byone or more systems of the reader.

At 404, a buffer can be added to the electrophoresis strip inpreparation for the electrophoresis testing of the collected bloodsample. The buffer can be a liquid that wets the electrophoresis stripand can contain salts or other compounds to assist with the applicationof a current across the electrophoresis strip. The buffer can be storedwithin the cartridge or the reader and applied by the cartridge orreader in response to starting an electrophoresis testing process, suchas by a user, the reader, the cartridge conditions, disorders, diseases,ailments, the like, or combinations or multiples thereof. Alternatively,the electrophoresis strip can have the buffer pre-applied during amanufacturing or other process. In a further embodiment, theelectrophoresis strip can include one or more components of the bufferthat are applied to the electrophoresis strip in a dry state, such asduring a manufacturing process, and a fluid, such as deionized water,can be applied to the electrophoresis strip prior to use to hydrate thedry state components and wet the electrophoresis strip with the buffersolution.

The collected blood sample 402 can then be treated, if necessary ordesired, for analysis. The treatment of the blood sample can includediluting the blood sample, which can be done by mixing the collectedblood sample with a dilutent, such as deionized water or other fluidthat dilutes the blood sample. The dilutent can alter the viscosity ofthe blood sample, the opacity or translucence of the blood sample, orotherwise prepare the blood sample for analysis using the reader.Preferably, the dilutent does not impact the resulting analysis of theblood sample or assists with preparing the blood sample for analysis.This can include lysing the cells of the blood sample to release thevarious cellular components for electrophoresis analysis by the reader.Lysing agents can include fluids, such as water or various chemicals,and powders. Additionally, mechanical lysing can be used, such as bysonication, maceration, or filtering conditions, disorders, diseases,ailments, the like, or combinations or multiples thereof, to achieveadequate lysing of the cells of the blood sample in preparation foranalysis of the sample. A higher percentage of a lysed sample can yieldmore of the compound or analyte of interest for analysis. For example,sonication can yield upward of 100% lysing (as compared to approximately50% in water for 4 minutes), thereby yielding more hemoglobin on themedia on which analysis or an assay is performed.

At 408, one or more markers can be added to the blood sample. The addedmarkers can assist with visualizing the completed electrophoresisresults. For example, a marker that moves at the same relative rate as ahemoglobin type due at a predetermined applied voltage can be added. Themarker will move with the hemoglobin type containing portion of theblood sample across the electrophoresis strip in response to the appliedvoltage. The marker can have a color, or other optical properties thatmakes visualizing the marker easier. Since the marker moves with therelative to a specific hemoglobin type, the easier to visualize markercan make it easier to determine the distance the hemoglobin type hasmoved across the electrophoresis strip in response to the appliedvoltage.

At 410 the blood sample can be deposited onto the electrophoresis stripin a controlled manner, preferably applied in a “line” perpendicular tothe length of the electrophoresis strip. The controlled manner ofdeposition can include controlling the amount of blood sample deposited,the area across which the blood sample is deposited, the shape of thearea across which the blood sample is deposited or other depositioncharacteristics. One or more systems or components of the reader orcartridge can be used to deposit the blood sample in the controlledmanner onto the electrophoresis strip.

Alternatively, the process 402 of collecting the blood sample can becombined with the deposition of the blood sample 410 into a single step.The patient blood sample can be directly deposited, such as from afingerstick, onto a region of the electrophoresis strip for analysis.

With the blood sample deposited onto the electrophoresis strip, avoltage can be applied across the electrophoresis strip at 412 to causethe separation of the blood sample into various bands of components. Thevoltage or current can be applied at a predetermined level or series oflevels and for an amount of time. As discussed previously, theapplication time of the voltage can be predetermined or based on themovement of one or more bands of the patient sample, measurement of anelectrical parameter such as resistance or an added compound orcomponent. A higher applied voltage can cause the bands to move acrossthe electrophoresis strip at a greater speed, however, the band shapecan be distorted making the interpretation of the banding difficult. Alower applied voltage can increase band fidelity but can take a longertime to perform the requisite testing. The applied voltage can beselected to optimize testing efficiency while maintaining a desired orminimum fidelity level. Further, the applied voltage can be variedduring testing, such as applying a higher voltage initially and thenapplying a lower voltage. The varied application of the voltage cancause the initial band separation and movement and the later appliedlower voltage can assist with increasing the fidelity of the resultantbanding pattern. Additionally, varying voltages or currents can beapplied during the electrophoresis process in response to a measurementof the bands formed by the blood or the band or bands formed by themarkers in a predetermined ratio, to maintain a constant rate of travelof the marker band or a portion thereof.

Additionally, environmental conditions within the reader or cartridgecan be controlled during the electrophoresis process. Control of theenvironmental conditions can be done to maintain a stable environment inwhich the electrophoresis process is performed in order to minimizepotential error and variance that can be caused due to environmentalfluctuations. For example, a heat sink can be thermally connected to theelectrophoresis strip, the cartridge or the reader, or portions thereof,to limit the temperature of the electrophoresis strip during testing toimprove or maintain the quality of the results.

After completion of the electrophoresis process, the electrophoresisstrip can be optionally stained at 414. Staining the electrophoresisstrip and the bands thereon can assist with the analysis or evaluationof the banding. For example, a stain for hemoglobin can be used to stainthe bands to assist with determining a position of the bands across theelectrophoresis strip. The cartridge or reader can include the stain andthe required systems or components for applying the stain to theelectrophoresis strip. Alternatively, a user can stain theelectrophoresis strip before band analysis. Alternatively or inaddition, a short high voltage can be applied at the end of the testessentially burning the hemoglobin bands and making them visuallypersistent. The high voltage may also reduce the risk of viablepathogens.

At 416, the electrophoresis strip can be optically analyzed, includingimaging the electrophoresis strip and the bands thereon. Theelectrophoresis strip can be imaged using one or more light sourcesemitting one or more spectrums of light. Multiple images of theelectrophoresis strip can be captured in various lighting conditions inorder to assist with analysis or evaluation of the bands. The imagecapture can be accomplished using one or more imaging sensors, such as adigital imaging sensor and can be performed throughout the testingprocess or at the conclusion of the test. The captured image(s) can beprocessed to evaluate or analyze the electrophoresis test results.

At 418, the final location of the bands can be calculated. Thecalculation can determine the distance each of the bands traveled, dueto the applied voltage during testing, from the initial blood sampleplacement on the electrophoresis strip. Along with the distance oftravel, a speed of travel of each band can be calculated based on theelapsed voltage application time and the distance traveled. Using theidentity and location of each of the bands, the various components orcompounds of the initial blood sample, and their proportions, can bedetermined. For a hemoglobin disorder test, this can include identifyingthe various hemoglobin types (HbS, HbA, HbF) present in the blood sampleand the proportions of each.

As part of the analysis of the electrophoresis tests, the bands formedduring the testing can be identified at 420. Identification of the bandscan include associating one or more compounds or components of theinitial blood sample with each of the bands of the electrophoresis. Forexample, identifying the bands can include associating each of the bandswith a hemoglobin type. The identification of the bands can be assistedby markers that were previously added to the blood sample prior to theelectrophoresis testing. The markers can be selected so that their finalposition along the electrophoresis test aligns with one or more of thecompounds or components of interest in the blood sample. Alternatively,the marker can be selected to be interspersed between two bands soassist with differentiating the bands for identification.

Once the analysis of the blood sample is complete, the results can beoutput 422. The output of the results can include the identified bloodcharacteristic(s), which can include a disorder, condition, disease orailment, the identification of the compounds or components of the bloodsample and relative proportions of each of the identified compounds orcomponents. For example, the results can include the identification ofthe various hemoglobin types present in the initial blood sample and theproportions of each hemoglobin type. The output can be displayed orrelayed to the user in a visual output, such as on a display, auditorysuch as by a speaker, or other manner. This can include transmitting theoutput results to an external device, such as a computer, through awired or wireless connection or communication protocol, such as by aBluetooth® connection.

FIG. 5 illustrates an example reader 500 and a cartridge 560. The reader500 can include all or a portion of the required systems or elementsrequired to perform analysis of a patient sample. The cartridge 560 caninclude none or a portion of the systems or elements required to performanalysis of the patient sample. The reader 500 and cartridge 560interface to perform the analysis, such as the method 400 of FIG. 4 , ofa patient sample.

The reader 500 includes a housing 502 that surrounds and encloses someportion or all of the reader components. FIG. 5 shows that the housingencloses all components of the reader 500, however, one of skill in theart will appreciate that any one or more components can be external tothe housing, as needed or desired. As previously discussed, the housing502 of the reader 500 is constructed of suitable materials which mayinvolve a suitably robust construction such that the reader 500 isrugged and portable. Alternatively, the reader 500 can be designed orconstructed for use in a permanent or semi-permanent location, such asin a clinic or laboratory. Example materials that can be included in thehousing 502 include plastics, metals, and composites. The housing 502can be constructed of multiple or a singular material and can includegeometry or structural features that enhance the usability of the reader500. Such features can include a smooth outer surface that is easilycleaned, grips or handles for carrying the reader 500, shock protectionor increased structural strength in locations to prevent damage to theinternal components of the reader 500, insulation or heat dissipationstructure(s) assist with maintaining a desired or a stable temperature,or range, within the housing 502, a membrane or construction to preventthe intrusion of moisture or dust into the interior of the reader 502,connections, ports or interfaces for connecting the reader 500 to anexternal element or device using a physical or wireless connection,instructions regarding the use of the reader 500, identificationmarkings such as a serial number or additional necessary or desirablefeatures that can facilitate the safe, effective, efficient or properuse of the reader 500. The housing 502 can feature access points, suchas removable or openable panels, to allow access to the interior of thereader 500 for maintenance or repair of the internal components,elements or systems of the reader 500. Additionally, the housing 502 ofthe reader 500 can be removable or separable from the other components,elements or systems of the reader 500, allowing the replacement of thehousing 502, easing the cleaning of the housing 502, providing access tothe components, elements or systems of the reader 500 or other abilitiesthat require or made easier by the removal of the housing 502 of thereader 500.

The portability of the reader 500 can be an important consideration inthe design and packaging of the reader 500, including the housing 502.The reader 500 may need to be rugged and easily transported so that itcan be moved to and used in a variety of embodiments. Considerations,such as operating environment and access to infrastructure, can beconsidered when designing or constructing the reader 500 such that thereader can be used safely, effectively, and efficiently in a variety ofenvironments or locations reliably. Depending on the environment of andinfrastructure available in a particular location in which the system isto be used, the housing can be customized to best operate in thatlocation by the addition or modification of existing reader features.Alternatively, the reader 500 can be designed or packaged to be morepermanently located, such as in a laboratory, clinic, or other setting.

The housing 502 of the reader 500 includes a cartridge interface 504that interacts with or engages the cartridge 560 for analysis of apatient sample. The cartridge interface 504 can be a slot that is shapedto receive the cartridge 560. Alternative designs or structures ofcartridge interfaces 504 can be used with the reader 500. Additionally,the cartridge interface 504 can include additional structures, such as adoor, that can effect insertion of the cartridge 560 within the reader500. The user inserts the cartridge 560 into the slot in preparation foranalysis of the patient sample. The slot can include internal geometrythat aligns or orients the inserted cartridge 560 in a proper alignmentor orientation for the components, elements or systems of the reader 500to perform the requisite or desired analysis of the patient samplecontained within the cartridge 500. For example, the cartridge interface504 can accept a variety of cartridges 560 having differentcross-sections, such as square, rectangular, and circularcross-sections. The unique shape of each cartridge 560, the uniquecross-section, can interact with the geometry of the cartridge interface504 to properly align the cartridge 560 within the reader 500 foranalysis. For example, the circular cross-section cartridge can insertinto the cartridge interface 504 to a first position at a firstorientation, the square cross-section cartridge can insert into thecartridge interface 504 to a second position at a second orientation.The various orientations and positions a specific cartridge 560 can beinserted into the cartridge interface 504 can be the same or differentfor multiple condition-specific cartridges 560.

The reader 500 can also include a cartridge verification system 540. Thecartridge verification system 540 can be integrated with or separatefrom the cartridge interface 504 or included internal to or externalfrom the reader 500. The cartridge verification system 540 can verifythe legitimacy of a cartridge to assist with efficient and effectiveanalysis of a patient sample. An example verification system 540 caninclude a verification element 569 of the cartridge 560 that interactswith the cartridge verification system 540 to verify the cartridge priorto further processing of the patient sample. Additionally, verificationof the cartridge 560 can include determining that the cartridge has notbeen previously used. The reuse of cartridges can be allowed or not andthe verification system 540 can be used to enforce the desired orrequired limitation on reuse of the cartridge 560. Once the cartridge isverified, further analysis of a patient sample contained within thecartridge can be allowed to proceed. The verification of the cartridgecan be the threshold analysis of the in vitro diagnostics process of thepatient sample, in some examples. This verification can include limitingthe analysis to a specific single or multiple analyses based on thecartridge verification.

A positive engagement or lock in the reader 500 can engage the cartridge560 when properly and fully inserted. This engagement can also provide atactile, audible, or visual cue to the user to signify proper insertionor interfacing of the cartridge 560 and reader 500. An example positiveengagement or lock can include a notch and protrusion arrangement, thenotch is sized to receive and releasably restrain the protrusion whenengaged such that the notch of one element, the reader 500 or cartridge560, engages the protrusion on the opposite element, reader 500 orcartridge 560, to releasably connect, interface with or engage the twoelements, the reader 500 and cartridge 560, together. When prompted,such as when the analysis is completed or an error situation, the usercan remove the cartridge 560 from the reader 500.

The cartridge interface 504 can also include an actuator or otherelement of the reader 500 that assists with the proper insertion orinterfacing of the cartridge 560 and reader 500. The actuator can engagethe cartridge 560 before the cartridge is fully inserted, the actuatorcan then position the cartridge 560 in a proper alignment or orientationwith the reader 500 for the reader 500 to analyze the patient samplewithin the cartridge 560. When prompted, such as automatically by thereader 500 or manually by the user, the actuator can “eject” ordisengage the cartridge 560 from the reader 500. The disengagement canfully or partially remove the cartridge 560 from the reader 500.Alternatively, the actuator can assist with the engagement orinterfacing of the cartridge 560 with the reader 500 and not with thedisengagement of the cartridge 560 and reader 500. In this example, theuser can be required to remove the cartridge 560 from the reader 500when prompted.

The cartridge interface 504 can be shaped to engage one or more specificcartridges 560, which prevents the insertion of an incorrect or impropercartridge 560 within the reader 500. The cartridge interface 504 canalso be reconfigurable, either manually by a user or automatically bythe reader 500 to accommodate a specific cartridge design to perform oneor more specific analyses of a patient sample. For example, a user caninput a desired or required analysis to be performed on a patientsample, the reader 500 can then reconfigure or prompt thereconfiguration of the cartridge interface 504 to accept a specificcartridge 560 that corresponds to the requested analysis.

For example, the cartridge interface 504 can include multipleconfigurable elements, such as panels, that can be configured orarranged automatically in response to a received analysis to beperformed, such as a user-selected disorder, condition, infection ordisease for which to analyze the patient sample. The now configured orarranged configurable elements of the cartridge interface 504 are in aspecific geometry into which only a compatible cartridge can beinserted. The analysis to be performed can be an input by a user intothe reader 500 or from a remote administrator or system. In a furtherexample, a specific cartridge interface 504 can include removable orreplaceable cartridge interfaces 504 that can be removed from orinserted in the reader 500. Each cartridge interface can includegeometry to accept a specific cartridge design(s). Additionally, theinserted cartridge interface 504 can be detected or otherwisecommunicated to the reader 500 and the reader 500 can limit availableoptions, such as the analyses that can be performed, based on theinserted cartridge interface 504. Each cartridge interface 504, orcartridge interface 504 design or geometry, can correspond to a specificanalysis or analyses. Further, the reader 500 can be limited to thespecific analysis or analyses corresponding to the particular cartridgeinterface 504 or cartridge interface 504 geometry.

In a further example, the cartridge interface 504 can initially acceptany inserted cartridge. Once a cartridge is inserted, the cartridgeinterface 504, a sensor or other reader 500 system or element can detectthe cartridge type and the corresponding analysis or analyses that canbe performed based on the cartridge type. The cartridge interface 504can manipulate the cartridge position or orientation, the reader 500 canproperly position or orient analysis systems or elements relative to thecartridge, or the cartridge interface 504 or reader 500 systems orelements can be configured to perform the analysis or analysescorresponding to the cartridge type.

Also, a sample processing module 532 of the processing circuitry 530 ofthe reader 500, or an external sample processing system or element, canalter the processing of the sample analysis data to correct, compensateor otherwise modify the collected sample analysis data based on the typeof cartridge inserted within the reader 500. Instead of or in additionto positioning or aligning the cartridge or reader 500 analysis systemsrelative to the reader, the processing of the collected sample analysisdata can be manipulated or modified to compensate based on the type ofcartridge inserted. Additional modifiers can include compensating forposition or alignment errors caused by improper alignment or positioningof the cartridge relative to the analysis systems or elements.

Further, the cartridge interface 504 can include multiple orientation oralignment features that engage specific cartridge 560 features toproperly align a specific, inserted cartridge with a specific analysisprocess. For example, a first cartridge for a first specific analysis isinserted into the cartridge interface 504 which guides, aligns, ororients the first cartridge properly in a first position for the firstanalysis to be performed, a second cartridge for a second specificanalysis can be interested in the same cartridge interface 504, whichcan properly guide, align, or orient the second cartridge in a secondposition for the second analysis to be performed. In this manner, thecartridge interface 504 ensures the proper positioning of a variety ofspecific cartridge designs within the reader 500 allowing acorresponding variety of specific analyses to be performed, eachanalysis corresponding to one or more specific cartridge designs.

The cartridge interface 504 can also include a number for positionpoints corresponding to various steps of analysis. For example, ananalysis can require that the cartridge 560 is inserted partially to afirst position within the reader 500 to perform a first step of theanalysis, the reader 500 can prompt the user to advance or move thecartridge 560 to a second position, such as further insertion of thecartridge 560 within the reader 500, to perform a further step of theanalysis. Each position can include a tactile, audible, or visualindication to a user manually inserting the cartridge 560 within thecartridge interface 504 to assist the user with properly position thecartridge 560 within the cartridge interface 504. An actuator, such asdescribed previously, can position the cartridge 560 at the variousanalyses required positions automatically, or can assist the user withthe cartridge 560 positioning.

Insertion of the cartridge 560 into cartridge interface 504 of thereader 500 can automatically initiate or prompt a user to initiateanalysis of the patient sample contained within the cartridge 560. Anactuator or sensor can be connected to the processing circuitry of thereader 500 and triggered by or sense the insertion of the cartridge 560to automatically initiate or to prompt a user to initiate the analysisof the patient sample. Initiating analysis of the patient sample caninclude powering-up, preparing, or running the various analyses systemsor devices, such as an electrophoresis module 506 and an electrophoresisband module 508. In some examples, the user need only insert thecartridge 560 in the reader 500 to actuate or trigger the entirediagnostics process to an output.

The cartridge interface 504 and additional elements, such as guides oractuators can be integrated into the housing 502 of the reader 500 orcan be separate components, elements or systems. Each of the additionalelements can be further separable from each other allowing forreplacement, substitution, repair or maintenance of the additionalelements as necessary or required.

The reader 500 can include a single cartridge interface 504, such as theexample shown in FIG. 1 , or can include multiple cartridge interfaces504 in the same reader 500. The multiple cartridge interfaces 504 canallow the reader 500 to analyze multiple patient samples simultaneouslyor in succession by allowing more than one cartridge 560 to beinterfaced with the reader 500. Additionally, each of the multiplecartridge interfaces 504 can accept the same or different cartridges toperform the same or different analyses. Further, in conjunction with amulti- or singular cartridge interface 504, a guide, rack, carousel orsystem can hold multiple cartridges in preparation for analysis. Theguide, rack, carousel or system can feed or guide, actively orpassively, cartridges 560 to the reader 500 by the cartridge interface504 allowing multiple patient samples or cartridges 560 to be analyzedwith minimal interruption between the analyses.

The reader 500 shown in FIG. 5 includes an electrophoresis module 506that can interface with the cartridge 560 to perform the electrophoresistest. The electrophoresis module 506, alone or in conjunction with theprocessing circuitry 530, can control the electrophoresis test,including voltage or current application time or amplitude. Theelectrophoresis module 506 can supply electrical power from a powersource 510 of the reader 500 to the cartridge 560, or electrophoresisstrip 564 directly, to establish the necessary voltage across theelectrophoresis strip 564 for testing. The voltage can be applied at ahigher level to increase the speed of the testing, however, theincreased speed can cause decreased band fidelity, which can increasethe difficulty and error of the band analysis and evaluation. A lowerapplied voltage can increase band fidelity but can lengthen the requiredtesting time. Alternatively, the electrophoresis module 506 can vary theapplied voltage or current, while maintaining the other stable, toachieve a desired or required level of band fidelity and testing speed.For example, an initial test to identify a patient condition can becarried out at a higher level voltage level to speed the test and asubsequent test to quantify the condition can be carried out a lowervoltage level to generate clearer or more accurate results.

The electrophoresis band module 508, alone or in conjunction with 530,can capture, analyze or evaluate the electrophoresis test results or anyother band detection characteristic(s) related to or otherwise based onthe electrophoresis test results. The electrophoresis band module 508can include an imaging device, such as a digital image sensor, tocapture an image of the electrophoresis strip and the banding thereon atthe conclusion of the electrophoresis test. Using the captured imagedata, each of the bands can be associated with one or more compounds orcomponents of the patient blood sample and the proportions of each canbe determined.

The electrophoresis band module 508 can include a detection module 522.The detection module 522 can detect, quantify, or both one or morecomponents of a patient sample during, after, or both ofelectrophoresis. The detection module 522 can use multiple time points,multiple wavelengths, change in voltage, change in intensity, the like,or combinations or multiples thereof to detect, quantify or both the oneor more components.

The detection module 522 can use multiple time points duringelectrophoresis, such as provided by multiple images or multiple timepoints in video, to detect and determine one or more of the componentsof the patient sample (e.g., Hb A versus Hb A2). The multiple timepoints can be used to determine the speed of the components (i.e.,change in location over change in time), the change in location, thechange in band width, the like or combinations or multiples thereof. Thedetection module 522 can also use images, video, or data associated withmultiple wavelengths emitted by multiple components. For example, Hb Acan emit a first wavelength and Hb A2 can emit a second wavelength (or,alternatively, first and second stains can be conjugated to Hb and HbA2, respectively, which can emit first and second wavelengths,respectively).

The detection module 522 can include an electrophoresis voltage which isthe applied voltage across the electrophoresis strip. The detectionmodule 522 can normalize or compare location, speed, or both against anapplied voltage. Therefore, a voltage that is less than or greater thana standard voltage, which can provide different results than thestandard voltage to be used to determine or detect accurate band orcomponent information. For example, a higher voltage can cause thecomponents to move faster, thereby providing larger separate betweendifferent components while also providing a wider band for theindividual components. As another example, a lower voltage can cause thecomponents to move slower, thereby providing for smaller separationbetween different components while also providing a narrower band forthe individual components.

The detection module 522 can include an emission intensity, anexcitation intensity, or both. A difference in emission intensities fromone sample to another can be used to determine a difference in theamount of the component or analyte of interest, to determine whether theexcitation wavelength properly stimulated or was absorbed by the stain,component, analyte, the like, or combinations or multiples thereof. Adifferent in excitation intensity can be used to prevent bleed throughfor different channels, to avoid bleaching or drowning out a stain,component, analyte, the like, or combinations or multiples thereof.

The detection module 522 can also include multiplexing of the sample ora component of the sample. Multiplexing is a process or kit by which asample is labeled with a plurality of stains. Each of the stains emitdifferent wavelengths. For example, at least two stains can be used tolabel the sample. Multiplexing can include up to 2, 4, 5, 6, 8, 10, 12,16, 20, 24, 30, 40, 50, 60, 70, 80, 90, 100, or more stains. The samplecan be multiplexed to differentiate between components (e.g., a firstcomponent is labeled with a first stain and a second component islabeled with a second stain). Individual components or analytes can bemultiplexed to differentiate between other components or analytes whichhave one or more of the same biomarkers. For example, a first analytecan have biomarker A, biomarker B, and biomarker C, and a second analytecan have biomarker biomarker D, and biomarker E. Labeling with a firststain conjugated to biomarker A would be imaged for both the first andsecond analytes. Labeling biomarkers B-E with different stains allowsfor differentiation between the first and second analytes.

A “stain” or “label” describes an emitting molecule bound to a bindingmolecule, such that the emitting molecule is capable of emitting anemission wavelength when stimulated by light at an excitation wavelengthand the binding molecule is capable of binding to or interacting with amaterial of interest. The binding or interaction between the emittingand binding molecules can be direct or indirect. The binding moleculecan be an antibody, a hapten, a protein, an aptamer, an oligonucleotide,a polynucleotide, or any appropriate molecule for interacting with orbinding to another molecule (e.g., a biomarker; a molecule of a bindingpair or a complementary molecule, including, without limitation, biotinor an avidin; or, the like). The emitting molecule can be a compound orsubstance which provides a signal for detection, thereby indicating thepresence of another compound or substance, an analyte, or the likewithin a sample or specimen. The detection moiety can be fluorescent,such as a fluorescent probe, or chromogenic, such as a chromogenic dye,or a visible particle such as gold nanoparticles. The fluorescent probecan be a reactive dye, an organic dye, a fluorescent protein, a quantumdot, non-protein organic molecules, a nanoparticle (e.g., nanodiamond),or the like.

The stain can help identify an analyte. The stain can also increase thelimit of detection of the analyte or make the analyte visible, such asfor imaging or detection. For example, the stain can allow for detectionat smaller concentrations of material. Labeling or staining an analytebefore performing electrophoresis allows for imaging (i.e., capturestill images or video) and sample analysis in real-time (i.e., duringthe test).

An antibody or other molecule capable of binding to or interacting withthe analyte (e.g., a hapten, a protein, an antibody, an aptamer, anoligonucleotide, a polynucleotide, or the like) can be developed orselected based on mass and charge to cause the analyte, when bound tothe antibody or other molecule (whether or not the antibody or othermolecule is bound to an emitting molecule), to move faster or slowerthan the analyte would without any other molecule bound to it. Forexample, in an area with bands close together a band containing ananalyte could be moved to a less crowded region making bandidentification easier.

The reader 500 can also include an optional sample treatment 550. Thesample treatment 550 can include a buffer solution for use with theelectrophoresis strip, markers to add to the blood sample, dilutents orother solutions or compounds for use in the electrophoresis testing. Thesample treatment(s) 550 can be contained within removable cartridges toease replacement or change of the sample treatment 550. Alternatively,the reader 500 can include internal containers for storing the sampletreatment 550. Associated tubing, systems or components can be includedto facilitate the transfer of the sample treatment 550 to the cartridgeor other systems or components of the reader 500.

The positioning and structure of the cartridge 560 within the reader 500can be such that one or both of the electrophoresis module 506 and theelectrophoresis band module 508 are properly aligned with the cartridge560 when inserted into the reader. The electrophoresis module 506 caninterface with contacts on the cartridge 560, or the electrophoresisstrip 564 itself, to supply the necessary voltage to the electrophoresisstrip 564. The electrophoresis band module 508 can be aligned to monitoror capture an image of the electrophoresis strip 564 during or after theelectrophoresis test.

The reader 500, the electrophoresis module 506 or the electrophoresisband module 508 can include an optional light source 555. The lightsource 555 can illuminate the electrophoresis strip 564 to assist withcapturing the electrophoresis results for analysis. Light emitted by thelight source 555 can be reflected from or transmitted through theelectrophoresis strip 564 to assist with imaging the electrophoresisstrip 564. Additionally, the light emitted by the light source 555 canhave constant or varying properties, such as a wavelength, intensity ora frequency of the emitted light. The light source 555 can include oneor more illumination elements to generate light having the required, ordesired, properties to assist with imaging or analyzing theelectrophoresis results. The light source 555 or elements thereof canhave an adjustable intensity. The light source 555 can include multipleillumination elements can each emit light in a different channel (i.e.,a wavelength range of an electromagnetic spectrum). For example, a firstlight emitting diode (LED) can emit light in a red channel, a second LEDcan emit light in a green channel, and a third LED can emit light in theUV channel. The LEDs can be used alone or together.

The reader 500 can include an optical imaging device 560 can image anelectrophoresis strip, during or after the electrophoresis process, forprocessing to identify the compounds represented by the various bandsand their relative proportions.

The optical imaging device 560 can acquire a set of images or video atan adjustable frame rate, or frames per second (FPS). In one example,the frame rate can be 1 FPS. In another example, the frame rate can begreater than 1 FPS, including at least 10 FPS, 24 FPS, 30 FPS, 120 FPS,240 FPS, 1000 FPS, 5000 FPS, 10000 FPS, or the like.

The optical imaging device 560 can capture images or video with highdynamic range (HDR) to provide enhanced image or video quality. Theimages or video can be taken at various exposures, at different f-stopsor different camera ISO settings, at different wavelengths, the like, orcombinations or multiples thereof. In one example, a first image can becaptured where an emission from the sample is at 415 nm and a secondimage can be captured where an emission from the sample is at 525 nm.The different wavelengths can be acquired across different images byusing one or more filters, one or more light sources, the like, orcombinations or multiples thereof. As another example, the settings ofthe optical imaging device 330 can be adjusted between images or overthe duration of the video.

The reader 500 can include an internal power source 510 that suppliesthe necessary power to run the components, elements or systems of thereader 500 to perform analysis of patient samples or preserve a minimal,required functionality of the reader. The power source 510 can supplypower to the processing circuitry 530, the electrophoresis module 506,the electrophoresis band module 508 or other component, elements orsystems of the reader 500. The power source 510 can include one or morebatteries or other energy storage devices that provide a required ordesired level of power for the reader 500. Additionally, the powersource 510 or a portion thereof can be external to the reader 500 andconnected thereto as needed or required. External power sources caninclude batteries or other energy storage devices or a connection to anearby power source such as a generator, municipal power, or solararray.

The reader 500 can also include pathogen neutralization 512. Thepathogen neutralization 512 can include physical components, such as adevice or system, or a chemical component. There are many differentmethods of pathogen neutralization and many different devices or systemscapable of performing the methods. The goal of pathogen neutralizationis to target specific undesirable biological material, such as diseasesand parasites, to neutralize or to destroy biological materialindiscriminately, such as by sterilization. Various systems, such asdevices or chemicals that interrupt biological processes or cause thebreakdown of biological materials can be to neutralize pathogens withina reader 500 or a cartridge 560.

An ultraviolet (UV) light source is an example pathogen neutralization512 device that could be used within the reader 500 is e. Exposure to UVlight has a debilitating effect on biological material and exposure tointense UV light can cause biological destruction. A UV light source canbe placed within the reader 500 and activated to bathe the interior ofthe reader in UV light, which neutralizes at least a portion of thebiological material, including pathogens, within the reader 500.Alternatively, the UV light can be continuously powered on when thereader 500 is in use. The UV light can also be targeted, with one ormore UV light sources placed in specific areas of the reader 500 toperform the desired pathogen neutralization. Additionally, the UV lightcan be positioned to penetrate or bathe a cartridge 560 inserted withinthe reader 500 to neutralize the patient sample within the cartridge 560after analysis has been performed. A timing device can be connected tothe UV light source to ensure that the UV light source is activated fora necessary amount of time to perform the pathogen neutralization. Aphoto- or light detector can also be included to monitor the output ofthe UV light source to check the continued efficacy of the UV lightsource or monitor the output of the UV light source to ensure it isactivated for a long enough duration to achieve a level of pathogenneutralization. The emitted UV light can affect materials, such asplastic, adversely causing them to become brittle. In some examples,shielding can be included within the housing 502 of the reader 500 toprotect areas, components, elements or systems which could be damaged byUV light exposure.

A further pathogen neutralization 512 system can include the use ofchemicals to neutralize biological material within the reader 500 orcartridge 560. A chemical based pathogen neutralization 512 system caninclude the application of chemicals within the reader 500 or cartridge560 on a temporary or permanent basis. That is, a chemical applicationcan be applied within the reader 500 during manufacture, the appliedchemical application can continuously destroy at least a portion ofbiological material that contacts a surface upon which the chemical wasapplied. A temporary chemical based pathogen neutralization 512 systemcan include a chemical dispersal system that deploys or applieschemicals within the reader 500 or cartridge 560 on actuation, thechemicals contact various surfaces, elements, components or systems ofthe reader 500, destroying at least a portion of biological materialthereon.

In an example embodiment, pathogen neutralizing chemicals, such as ableach-based solution, can be sprayed, fogged, or distributed about theinterior of the reader 500 or cartridge 560 to perform the pathogenneutralization. The pathogen neutralizing chemicals can be added to thereader 500 or cartridge 560 by a user, contained within a vessel that ishoused, inserted within or fluidically connected to the reader 500. Thepathogen neutralizing chemicals, such as the bleach-based solution, canbe prepared as needed or can be prepared and stored for later use. Anindicator or timer can be included that can indicate to a user once thepathogen neutralization process is complete. The indicator or timer canalso prevent the use of the reader 500 until the pathogen neutralizationprocess is complete. As with the previously described pathogenneutralization systems, the chemical-based pathogen neutralizationmethod can also neutralize at least a portion of biological material onor within a cartridge 560 inserted within the reader 500. Additionally,the chemical-based pathogen neutralization chemicals can be pumped ortransported through the various components, elements or systems of thereader 500, to disinfect portions that can contact a patient sample,which helps to prevent cross-contamination of patient samples.

An example pathogen neutralization system to neutralize at least aportion of the pathogens of the cartridge 560 can include a portion thatis included in the cartridge 560. Pathogen neutralization material, suchas powders, fluids or other components can be included in the reader 500or cartridge 560 assist with neutralization of pathogens within thecartridge 560. The pathogen neutralization material can be included in aportion of the cartridge 560 and dispersed into the collected sample orother portions of the cartridge 560 upon actuation, such as by a user,the reader 500, the cartridge 560, or another source. The pathogenneutralization material can also be integrated with a portion of thecartridge. Alternatively, the pathogen neutralization material can beincluded in the reader 500 and the reader 500 can circulate, orotherwise insert, the pathogen neutralization material into thecartridge 560. The pathogen neutralization material can be targeted to aspecific pathogen or be a general wide spectrum pathogen neutralizer.

The reader 500 can include an output 514 that includes one or morevisual 516 or audible 518 outputs although in other examples the outputis data and does not include visual or audible outputs. The output 514shown in FIG. 5 communicates information regarding the status of thereader 500, the results of analysis of a patient sample, instructionsregarding use of the reader 500 or other information to a user or othercomputing device. The visual 516 output 514 can include a display, suchas a screen, such as a touchscreen, lights, or other visual indicators.The touchscreen used to display information, such as analysis results,to the user can also be used by a user to input to the reader 500.Alternative interfaces can be included on or connected to the reader500, such as a keyboard or mouse. Additionally, user devices, such as acellphone or tablet, can be connected to the reader 500 to provide aninterface portal through which a user can interact with the reader 500.The audible 518 output 514 can include a speaker, buzzer, or otheraudible indicators. The output 514, visual 516 or audible 518, can beoutput through an external device, such as a computer, speaker, ormobile device connected physically or wirelessly to the reader 500. Theoutput 514 can output data, including the collected analysis data orinterpretative data indicative of the presence or absence of a disorder,condition, infection or disease within the patient or the patientsample. An example can include the identification and proportions of thevarious hemoglobin types within the patient sample. The interpretivedata output can be based on the analysis data collected and processed bythe processing circuitry 530 of the reader 500.

The output 514 can display, transmit, or both continuous images, whetherin still image format or video format, in real-time as the assay isbeing run. The output 514 can also display a final image or selectedimages from the images or video acquired of the assay. In one example, avideo is acquired in real-time and images at certain time points (e.g.,every second, up to and including the end time of the assay) areextracted from the video and displayed on the output 514 (or, thedisplay 514 can transmit the images or video to an external device via awired or wireless connection). In another example, images are acquiredat certain time points (e.g., every 2 seconds, up to and including theend time of the assay) in real-time during the assay run and displayedon the output 514 (or, the display 514 can transmit the images or videoto an external device via a wired or wireless connection).

The processing circuitry can acquire a video of the patient sample inreal-time, such that at least a portion of the video is acquired duringelectrophoresis. The processing circuitry can acquire at least twoimages of the patient sample in real-time, such that at least one imageis acquired during electrophoresis.

The output 512 can also display, transmit, or both data collected duringthe assay, after the assay, or both. The output 512 can also display,transmit, or both measurements, analyses, or results calculated ordetermined by the algorithm during the assay, after the assay, or both.

The reader 500 can also include temperature control 520. The temperaturecontrol 520 can actively or passively control the temperature of atleast a portion of the reader 500. Active temperature control 520 caninclude heating or cooling a portion of the reader 500 or cartridge 560.Temperature control 520 can also include heating one portion of thereader 500 or cartridge 560 and cooling another portion of the reader500 or cartridge 560. The temperature control 520 can include arefrigeration system, resistive heater, infrared heater, thermoelectricelements, radiator, or other temperature control devices or systems.Passive temperature control can include structures to contain a thermalmaterial in portions of the reader 500 or cartridge 560. This caninclude holders for ice, hot water, ice packs, and other thermalmaterials, the holders retain the thermal material in portions of orabout components, elements or systems of the reader 500 or cartridge560.

The reader 500 or cartridge 560 can also include a filter. The filtercan attract, extract, collect or otherwise remove unwanted components orparticles in a patient sample of the cartridge 560 or concentrate thewanted components or particles. The filtering of the patient sample bythe filter can occur as the patient sample is transferred from thecartridge 560 into the reader 500 or the patient sample can betransferred from the cartridge 560, through the filter and back into thecartridge 560 for analysis or internal to the cartridge 560. The filtercan include structural and chemical features that allow the filter toremove desired or required components from the patient sample. Thefilter can be affixed in a stationary position to contact the patientsample or moveable through the patient sample to filter the patientsample.

Processing circuitry 530 can be included in the reader 500 to receiveinput from various components, elements or systems, such as theelectrophoresis module 506 or the electrophoresis band module 508, ofthe reader 500. The processing circuitry 530 can process the receivedinputs to perform analysis of the patient sample and output results ordata of that analysis. The processing circuitry 530 can include a sampleprocessing module 532, a network module 534, a maintenance module 536and a database 538. The various elements, 532, 534, 536, 538 and others,of the processing circuitry 530 can be removable or replaceable,allowing replacement and addition of various elements to the processingcircuitry 530. In example embodiments, all or a portion of theprocessing circuitry 530 can be included in the reader 500 and a portionof processing circuitry included in the cartridge 560. The processingcircuitry 530 can also control the various components, elements orsystems, such as pathogen neutralization 512, the electrophoresis module506, the electrophoresis band module 508, and others, of the reader 500.

The processing circuitry 530 can initiate or control the analysis of apatient sample within a cartridge 560. The processing circuitry 530 caninclude preset routines, which may be defaults or selectable by theuser, that can be executed by the reader 500 to analyze a patientsample. The preset routines can include prompts for user input or theprocessing circuitry 530 can prompt a user for input before, during orafter analysis of a patient sample. User prompts can includeacknowledgement or authorization to proceed through one or more portionsof the analysis process. Alternatively, the processing circuitry 530 caninitiate, perform, or direct the analysis of the patient sampleautomatically without user prompts. The processing circuitry 530 canproceed through the various processes and procedures of an analysis of apatient sample, engaging any one or more of the reader 500 systems andcollecting the analysis data. The processing circuitry 530 can furtherautomatically process the collected data and transmit a result to a useror other, including an indication the analysis is complete, informationregarding the analysis or other indications. The processing circuitry530 can also transmit the collected data to an external system or devicefor processing and can transmit a result to the user or the result canbe transmitted by one or more of an external system or device.

The sample processing module 532 can receive inputs from theelectrophoresis band module 508. Based on the received band detectiondata the sample processing module 532 can determine at least acharacteristic of the patient sample, such as a disease or condition, anidentity of the various compounds or components of the patient sampleand quantification of the various compounds or components of the patientsample. The sample processing module 532 can output the identificationand proportions of the compounds or components, or other various databased on the analysis of the patient sample. For example, the sampleprocessing module 532, using the band detection data from theelectrophoresis band module 508, can identify and quantify the varioushemoglobin types of the patient sample. The output from the sampleprocessing module 532 can be transmitted through the output 514 of thereader 500 or transmitted to an external device or system, such as acomputer, mobile device, and remote server or database.

The sample processing module 532 can analyze the patient sample todetermine a hemoglobin characteristic, such as a hemoglobin affectingdisease or condition, based on the data from various components,elements or systems of the reader 500. The results of the analysis canbe output from the sample processing module 532 to the output 514 toconvey the information to a user or other.

A network module 534 can be included in the processing circuitry 530.The network module can allow the reader 500 to communicate with otherreaders, computing devices, servers, databases or other devices orsystems. The network module 534 can communicate with another devicethrough a physical, such as a local area network (LAN), Universal SerialBus (USB), or wireless, such as Bluetooth®, connection. In an example,the reader 500 can communicate to a remote server through the networkmodule 530 allowing the reader to upload patient sample analysis to thepatient's medical records stored on the remote server. The networkmodule 534 can transmit a communication to the reader 500, receive acommunication from the reader 500, or both. In another example,information on the patient can be downloaded to the reader and added tothe display or output or used in the analysis(es). For example,demographic information such as age, sex, etc. Information on priorresults or health history could also be used to modify the analysisperformed in the Reader 500.

A maintenance module 536 can be included in the processing circuitry530. The maintenance module 536 can perform, initiate or promptmaintenance, calibration, or other processes of the reader 500.Maintenance of the reader 500 can include automatically, or by promptinga user, clean a portion of the reader 500, replenish resources of thereader 500 and other regular or unscheduled maintenance of the reader500. Calibration of the reader 500 can include testing components,elements or systems of the reader 500 to check if the reader 500 is inan effective operable state or to adjust measurement or analysisparameters to take the measured state of the machine into account.Additionally, the calibration of the reader 500 can be performed by themaintenance module 536 or prompt a user to perform necessary calibrationprocedures to allow the reader 500 to perform patient sample analysiseffectively and correctly. The maintenance module could also allowautomated or semi-automated ordering of supplies or service.

A database 538 can be included in the processing circuitry 530. Thedatabase can record images, patient sample analysis data, patient data,statistical data, test conditions, and other data. The network module534 can communicate with the database 538 exporting or importing data.The database 538 can be stored on removable or permanent data storagewithin the reader 500. The database can also occur in whole or in partremote from the reader.

Statistical data of the database 538 can be used during analysis of apatient sample by the sample processing module 532 to assist or performthe analysis of a patient sample. Additionally, the database 538 caninclude statistical analysis techniques or algorithms that can be usedby the sample processing module 532 to determine, calculate or otherwiseanalyze the patient sample. The database 538 can also include specificinformation, such as prior patient analysis results. Such results can beused to determine if the detected condition is new or an existingcondition. Additionally, the severity of the condition can be trackedfor a particular patient to assess their treatment progress.

The cartridge 560 can contain the patient sample for analysis. Thecartridge 560 can be inserted in the cartridge interface 504 and thepatient sample analyzed or transferred to the reader 500 for analysis bythe components, elements or systems of the reader 500. The cartridge 560can include a blood collection device or system 562, an electrophoresisstrip 564, a buffer 566, a temperature control device or system 568 anda verification element 569.

Blood collection 562 of the cartridge 560 can include a device or systemfor collecting, storing, or analyzing a patient's blood sample, whichcan include a passive or active blood collection device or system, ablood sample storage chamber, a blood sample analysis chamber or otherchambers, devices or systems to assist or facilitate the collection of ablood sample and analysis of the blood sample.

Active blood sample collection can include the use of a needle,capillary tube or pipette. In an example embodiment, the cartridge 560can include a needle that can be actuated to deploy from the cartridge560, piercing a patient's skin and extracting a sample that is drawninto the cartridge 560 and stored for analysis. A further active bloodsample collection 562 can be a pipette-like system. The user or othercan apply pressure to a bulb or deformable portion of the cartridge 560,the release of pressure on the bulb or deformable portion can draw atleast a portion of a patient blood sample into the cartridge 560. Thepatient can be lanced, poked or pierced to cause bleeding, the blood canbe sampled to draw at least a portion of the blood into the cartridge560 for analysis.

The blood collection 562 can include a lancet or a piercing instrumentthat can pierce skin to cause bleeding. The blood can be collected usingthe cartridge 560 to obtain the patient blood sample. Collection of theblood sample can include retraction of the lancet or piercinginstrument, carrying a portion of the patient blood into the cartridge560 for analysis. The blood collection 562 can also include a sealedchamber that has a negative internal pressure. A needle can pierce thepatient and pierce the sealed chamber, the negative pressure of thesealed chamber causing blood to flow into the sealed chamber due to thepressure differential.

The blood collection 562 can also include a capillary tube that canpassively collect a blood sample using capillary action. The patient iscaused to bleed, such as by a lancet or other inducing technique, andthe capillary tube is placed in the blood to draw a sample into thecapillary tube of the cartridge 560 for analysis.

The cartridge 560 can include a filter to filter the patient samplewithin the cartridge 560. The filter can be placed to filter the patientsample as it is drawn into the cartridge 560 through, before or afterthe blood collection 562. In another example, the filter can filter thesample after it has been stored in the cartridge 560. As previouslydescribed, the filter can include structural or chemical features tofilter a patient sample as necessary or desired.

Preparation of the patient sample can include lysing of the patientsample. The reader 500 can also include mechanical lysing. Mechanicallysing can assist with the lysing of cells of a patient blood samplewithin a cartridge 560 or the lysing of the patient blood sample withinthe reader 500. Mechanical lysing can include a physical disruptor, orportion thereof, an agitator, a sonicator that can apply sound energy tothe patient sample, filtering of the patient sample or other mechanicallysing device or system. The mechanical lysing can interface with orengage the cartridge 560 to facilitate the lysing of the patient sample.The mechanical lysing can be mechanically powered, such as by a woundspring, or electrically powered, such as by a reader 500 power source510.

Alternative methods of lysing can include chemical lysing of the patientsample. Chemical lysing can include mixing the patient sample with oneor more compounds or substances to cause lysing of the patient sample.For example, the patient sample can be mixed with a dilutent, such aswater, that is selected to cause lysing of the patient sample. As withmechanical lysing, a requisite amount of time can elapse before analysisof the patient sample is performed in order to allow adequate lysing ofthe patient sample to occur.

The electrophoresis strip 564 of the cartridge 560 is a piece ofmaterial on or through which the electrophoresis test occurs. Theelectrophoresis strip 564 can be a variety of shapes, such as a strip,and composed of a variety of different materials, such as celluloseacetate, glass fibers or agarose gels. The cartridge 560 can include anopening in which the electrophoresis strip 564 is positioned oraccessible to one or more systems or components of the reader 500, suchas the electrophoresis module 506 or electrophoresis band module 508.Alternatively, the cartridge 560 can include a transparent ortranslucent portion(s) about electrophoresis strip 564 through whichsuitable imaging of the electrophoresis strip 564 can be performed toobtain the electrophoresis results.

A buffer 566, for use with the electrophoresis strip 564, can beincluded in the cartridge 560. The buffer 566 can be a conductivesolution that may also modify the chemical environment the test is runin, for example by controlling the pH, that is applied to theelectrophoresis strip 564 prior to an electrophoresis test. Certainmaterials of the electrophoresis strip 564 can require the use of abuffer 566 to perform an electrophoresis test. A chamber of thecartridge 560 can store the buffer 566 and the reader 500 or user cancause the buffer 566 to be applied to the electrophoresis strip 564.Alternatively, a buffer can be stored within the reader 500 and appliedto the electrophoresis strip 564 prior to a test. The cartridge 560 caninclude various routing to transfer the buffer 566 from an internalchamber of the cartridge 560 or from the reader 500 to theelectrophoresis strip 564.

Additional sample treatment solutions or materials, such as a dilutent,can be included in the cartridge 560. Dilutent can be used to dilute,treat or prepare the patient sample for analysis. The dilutent can bestored within the cartridge 560 separate from the patient sample andmixed automatically or manually. The dilutent can be pre-loaded in thesame chamber, a mixing chamber or patient sample chamber in which thepatient sample is stored within the cartridge 560. The user could alsoadd the dilutent or it could be stored in the reader.

The cartridge 560 can also include temperature control 558, which caninclude active or passive temperature control systems or methods.Passive temperature control 558 can include insulation, structuraldesign features or chemical design features. The passive temperaturecontrol 558 can maintain the temperature of the cartridge 560 topreserve a collected patient sample. Active temperature control 558 caninclude electronic elements, such as thermoelectric elements that canheat or cool at least a portion of the cartridge 560, for example toregulate the temperature of the cartridge 560 or a portion thereof.Temperature control 558 can include heating or cooling the temperatureof the cartridge before, during or after the collection of a patientsample or the analysis of the sample. The temperature control 558interfaces with the reader 500 or an external device to regulate thetemperature of the cartridge 560.

FIG. 6 is a further example cartridge 600, which can include a bloodsample collector 610, an electrophoresis strip 620, a treatment chamber630, or a sample depositor 640. The various components of the cartridge600 can be arranged in various configurations depending on the analysisto be performed or other environmental or use considerations. In theexample shown in FIG. 6 , the cartridges 600 components can beinterchangeable allowing a complete cartridge 600 to be assembled fromvarious components.

The blood sample collector 610 of the cartridge 600 can collect a bloodsample from a patient. The collector 610 can include devices, componentsor systems to assist or perform the collection of the blood sample froma patient. The blood sample collector 610 can include a capillary tube612 or a lancet 614. The capillary tube 612 can use capillary action todraw a blood sample into the cartridge 600. The lancet 614 can be usedto pierce, puncture or cut a patient's tissue to cause bleeding, fromwhich a blood sample can be taken.

The collected blood sample can be collected in a blood sample chamber ofthe cartridge 600. The blood sample chamber can include a filter tofilter the blood sample. The filter can be positioned within the bloodsample chamber of the cartridge 600 such that the blood sample chamberis divided into a first and second portion, which are separated by thefilter. The blood sample chamber can include structural or chemicalfeatures to assist with the storage of the blood sample or the analysisof the blood sample. Additionally, the blood sample chamber can belocated within the cartridge 600 to assist with or facilitate theanalysis of the blood sample using a reader.

An electrophoresis strip 620 can be included with the cartridge 600. Theelectrophoresis strip 620 can include a strip of material 622 on orthrough which the test is conducted and a pair of electrodes 624 toapply the necessary voltage across the strip 622. As previouslydiscussed, the strip 622 can be made of a variety different suitablematerials that can support an electrophoresis process. The electrodes624 can be disposed at opposite ends of the strip 622 to apply a voltageacross the strip 622 as part of the electrophoresis testing process. Thecartridge 600 can include external contacts that are connected to theelectrodes 624 and can interface with a reader device to supply electricpower to the electrodes 624. Alternatively, the electrodes 624 or thecartridge 600 can include an inductive power mechanism to facilitate thewireless transmission of power to the cartridge 600 or the electrodes624.

The treatment chamber 630 can store one or more materials for use in theelectrophoresis process, including a buffer 632 and markers 634. Thebuffer 632 can be a solution that is applied to the strip 622 prior toan electrophoresis test. The cartridge 600 can include internalstructures to facilitate the transfer of the buffer 632 from thetreatment chamber 630 to the strip 622. An example buffer can includeTris-Borate-EDTA (TBE) buffer. The buffer solution is electricallyconductive and assists with application of a voltage across the strip622 by the electrodes 624.

Markers 634 can be various compounds or components that can be mixedwith the blood sample prior to the test. The markers 634 can have anoptical property, such as a color, and known electrophoresis properties,such as moving a known distance along an electrophoresis strip in a setamount of time at a known voltage level. Markers 634 can be selected tomove at the same rate as a compound or component of the blood sample orat a different rate. A marker 634 moving at the same rate as a compoundor component of the blood sample can be used assist with visualizing afinal position of a band associated with that particular compound orcomponent. Alternatively, a marker 634 can be selected so that at theconclusion of an electrophoresis the marker is positioned between twobands of compounds or components of the blood sample or before or afterall bands. The marker positioned between or after the two bands canassist with distinguishing the bands from each other during analysis orevaluation of the band data.

The treatment chamber 630 can be composed of multiple chambers toisolate the various treatment materials from each other. The cartridge600 can include various structures to transfer materials from thetreatment chamber 630 to various other portions of the cartridge 600.The movement of materials from the treatment chamber 630 can initiatedby a reader, user interaction with the cartridge 600 or anotherinitiation event or source. A passive process, such as gravity or acapillary action, can be used to move the material from the treatmentchamber 630. Alternatively, an active process can be used, such as apressure differential. A user or reader can power the active transferprocess to move the materials from the treatment chamber 630.

The various chambers of the cartridge 600 can be interconnected or influid communication, allowing or facilitating the movement or transferof fluid, with one or more of the chambers of the cartridge 600 or aconnection to an external fluid source. The fluid communication betweenchambers can allow the blood sample, the treatment chamber 630 or otherfluids to flow or be transferred from chamber to chamber(s) and caninclude passageways like flexible, rigid, and semi-rigid pipes andtubes. Flow control elements, such as valves, can be positioned alongone or more of these passageways to regulate the fluid communicationbetween chambers. The flow control elements can be manually actuated,such as by a reader or user applying pressure to the cartridge 600 oractuating the flow control element, or electrically actuated, such as bya signal from the reader or a user initiated signal or trigger.

The cartridge 600 can also include a sample depositor 640, or a portionof a sample depositor system. The sample depositor 640 can deposit anamount of the collected blood sample onto the strip 622 in a controlledmanner. A controlled manner can include the amount of blood sampledeposited, the area over which the blood sample is deposited, the shapeof the area or other blood sample deposition characteristics. For theelectrophoresis testing, confining the deposited blood sample in a thin,or narrow, line initially can assist with the resultant band fidelitydue to the uniform nature from which the compounds or componentsdisperse from the initial deposition of the blood sample onto the strip622. Example depositors 640 can include a shaped orifice(s) throughwhich an amount of the blood sample can be metered, a shaped applicatorthat applies a portion of the blood sample to the strip 622 or othermeans. The sample depositor 640 can operate alone, or in conjunctionwith a reader, to deposit a controlled amount and shape of the patientblood sample onto the strip 622.

FIG. 7 is an example patient sample analysis process 700 of a reader,processing circuitry, a device or system external to a reader or acombination thereof. The reader can receive a cartridge containing apatient sample 702, such as the insertion of a cartridge within acartridge interface, the reader, or an external device connected to thereader or an external device or system. The cartridge can be optionallyverified 704 to determine the validity of the cartridge or the patientsample within. The reader can then identify the analysis to be performedon the patient sample based on a cartridge feature 706, such asstructural feature of the cartridge. That is, the reader can recognizeor identify the cartridge type and a corresponding analysis that can beperformed on the patient sample contained within. Alternatively, thereader can receive an input regarding the analysis to be performed onthe patient sample 708. The input can include a user selecting ananalysis, communication from an external system or device indicating theanalysis performed or other input directing the reader to perform ananalysis of the patient sample. Optionally, a portion of the patientsample can be transferred from the cartridge into a sample chamber 710of the reader so that the patient sample can be analyzed within thesample chamber. Additionally, the patient sample can optionally beprepared for analysis 712, which can include applying a buffer to anelectrophoresis strip, adding one or more markers to the patient sampleor other preparation performed on or to the patient sample prior topatient sample analysis. The patient sample is then analyzed 714 by thereader and its systems or an external device or system. The patientsample analysis data is then output 716, such as transmitted to a readeror an external device or system. The output 716 can include measurement,images and interpretive data, such as the presence or absence of acondition, disease or infection within the patient sample, includingdetailed information, such as the type and degree of the disorder,condition, disease or infection.

The sample analysis process 700 can include an algorithm to analyze thepatient sample, such as in the analysis step 714, to output theanalysis, such as in the output step 716, or both. Multiples images,whether still images or acquired from a video, can be analyzed by thealgorithm in real-time (i.e., during the assay), after the assay iscomplete, or both. For example, the algorithm can acquire or calculatemeasurements at one time point or at multiple time points across theduration of an assay run to aid in determining final test results. Bandposition, band thickness, and band speed can be measured multiples timesduring the assay run. Band position, band thickness, band speed, thelike, or combinations or multiples thereof can be used to determinewhich component of the sample is associated with which band. Forexample, in one sample, a hemoglobin A variant (Hb A) can move fasterand have a wider band than a hemoglobin A2 variant (Hb A2). Bydetermining the band speed and the band width (e.g., increasing bandwidth), the Hb A and HB A2 variants can be distinguished during theassay. Acquiring in-assay data (i.e., data acquired while the assay isrunning) regarding the two variants during the assay can provideadditional data to use at the end of the assay to distinguish betweenthe variants, such as when the bands of the variants areindistinguishable (i.e., being too close together).

The algorithm can calculate or determine band measurements, such as aband quantification, in real-time during the assay when the highestquality data is available for the particular band measurement. Thehighest quality data can be align with or not align with the time pointat which the band of interest is identified. For example, a first bandis identified at a first time point. The highest quality data for firstband quantification occurs at a third time point. An image, and the dataassociated therewith, aligning with the third time point can be used tocalculate the band quantification of the first band.

The algorithm can also determine the effectiveness of the assay run. Asthe images or videos are processed or analyzed by the algorithm, thealgorithm can determine whether or not the assay is being run properly,whether or not the data collected or generated can generate significantresults, the like, or combinations or multiples thereof. Theeffectiveness of the assay run, as determined by the algorithm, canpermit the algorithm to generate an instruction or message to instructthe reader 500 to stop the assay (i.e., no additional assay time isrequired or necessary), to extend the assay (i.e., additional assay timeis required or necessary), to trigger a re-run of the assay (i.e., assayis to be run again), the like, or combinations of multiples thereof. Theinstruction or message can cause the display 514 to display, transmit,or both an error message (e.g., “Error during assay,” etc.), a suggestedsolution (e.g., “Perform a new test,” “Test time is being extended,”etc.), the like, or combinations or multiples thereof.

To determine or calculate an electrophoresis measurement orelectrophoresis effectiveness, the algorithm can analyze real-time data,such as by comparing the real-time data against a threshold orpre-determined value, by extracting and comparing waveform features fromthe real-time data signal, by performing template correlations with thereal-time data signal (i.e., matching measured data to a template ofdata to smooth data or remove or reduce noise), look-up tables, thelike, or combinations or multiples thereof.

FIG. 8 illustrates an example cartridge 800 and various patient sampleanalysis devices or systems in relation to the cartridge 800. Thepatient sample analysis devices or systems can be included on a readerinto which the cartridge 800 is inserted or received, the cartridge 800can be inserted or received in a specific alignment or orientation inrelation to the patient analysis devices or systems of the reader.Additionally, one or more portions of or a complete patient sampleanalysis device or system can be included with the cartridge 800.

A blood sample collector 802 can be included on the cartridge 800. Theblood sample collector 802 can include a capillary or other tube,through which a patient's blood sample can be transferred into thecartridge 800. A capillary tube can use capillary action to draw theblood sample into the cartridge 800. A tube can be part of a pipette orpipette-like device or system of the cartridge 800, application andrelease of pressure on, or deformation of a portion of the cartridge 800can cause a blood sample to be drawn through the blood sample collector802, or portion thereof, due to a pressure differential between thesurrounding environment and an internal portion or chamber of thecartridge 800.

The blood sample collector 802 can include a lancet or needle that canbe used to cause a patient to bleed or with which to take the bloodsample from the patient. The lancet or needle can be releasably orpermanently affixed to the blood sample collector 802 or can extend orretract automatically or manually from the blood sample collector 802 toassist or facilitate the collection of a blood sample from a patient.

Alternatively, a patient blood sample can be obtained by other means ormethods, and a portion of the patient blood sample can be transferredinto the cartridge 800 through the blood sample collector 802 or throughanother input into the cartridge 800. For example, a blood sample can bedrawn from a patient, for use in multiple analysis or diagnosticservices, using a traditional method such as a needle and vacuum sampletube. From this collected blood sample, a portion of the sample to beanalyzed using the cartridge 800 or a reader can be transferred into thecartridge 800 for analysis. In this manner, the patient is pierced aminimal number of times, drawing enough blood to run necessarydiagnostic tests and analyses, including those using the reader orcartridge 800.

The cartridge 800 can be divided into multiple portions and each portioncan include one or more internal chambers that can contain a fluid, suchas a buffer, dilutent, a marker, a blood sample, or a combination of theblood sample and the marker. One or more internal chambers can also beempty allowing fluids to be introduced or mixed within in preparationfor analysis or additional or alternate purposes. The internal chambercan be interconnected, such as by conduits or tubes, to allow fluidcommunication between the various chambers. Flow control devices canregulate flow of fluids or gases from one or more chamber to anotherchamber(s). Internal chamber(s) within the cartridge 800 can span acrossone or more portions of the cartridge 800. That is, a single internalchamber occupies space in both the first portion and second portion ofthe cartridge 800.

The cartridge 800 can include a sample chamber 810 in which thecollected blood sample can be stored or prepared for analysis. Thesample chamber 810 can be divided into multiple portions, orsub-chambers, to separate the collected blood sample from varioustreatment materials, such as one or more markers. A first portion canreceive the blood sample, which can then be passed through a filter,passively or actively or in response to an input, such as by a readerinto which the cartridge 800 is inserted, into a second portion of thesample chamber 810 in which the treatment of the blood sample can beperformed. The portions of the sample chamber can also be separated by abarrier that prevents or controls the flow of the blood sample betweenthe portions of the chamber due to the geometry of the barrier,including openings disposed through the barrier. The barrier can beimpermeable and block the flow of the blood sample between the portionsof the sample chamber 810 until the barrier is selectively removed, suchas by moving the barrier, including by inductively moving or controllingthe barrier, or destroying the barrier, including puncturing thebarrier, to allow the flow of the blood sample between the portions ofthe sample chamber 810. Alternatively, the barrier can be dissolvable,completely, or partially, to allow the flow or control the flow of theblood sample between the portions of the sample chamber 810. The barriercan also be semi-permeable to control the flow, such as a flow rate, ofthe blood sample between the portions of the sample chamber 810. In anexample, a filter placed between the portions of the sample chamber 810can be a semi-permeable barrier that controls the flow of the bloodsample between the portions of the chamber 810.

A collected sample can be stored within the sample chamber 810 or storedin a different chamber and then transferred into the sample chamber 810in preparation for analysis. Additional materials or fluids can be addedto the sample chamber 810 to mix with a sample in preparation foranalysis. Additionally, the sample chamber 810 can be preloaded withvarious materials or fluids that can be mixed with the sample inpreparation for analysis, including stabilizing or preserving thesample, dilution of the sample, markers, reagents or other processes orprocedures.

The prepared sample, such as by the addition of one or more markers tothe collected blood sample, can then be transferred to theelectrophoresis section 820 of the cartridge 800. The electrophoresissection 820 can be in fluid communication with the sample chamber 810 toallow the prepared sample to be transferred for testing purposes. One ormore flow controls can be used to control the flow of the preparedsample between the chamber 810 and section 820. The flow can becontrolled by a reader when the cartridge 800 is placed therein.Alternatively, other sources, such as a user or the cartridge 800 itselfcan control the flow of the treated sample.

The electrophoresis section 820 of the cartridge 800 includes anelectrophoresis strip 822 and electrodes 824 and 826 disposed at eitherend. In the example shown in FIG. 8 , an electrophoresis test is inprocess or completed as evidenced by the displayed banding. Prior to theinitiation of the test, a buffer can be applied to the electrophoresisstrip 822, such as by a buffer solution stored in the sample chamber810, the electrophoresis section 820, a reader or another source.Alternatively, the electrophoresis strip 822 can have a bufferpre-applied, such as during a manufacturing process of the cartridge800, by a user prior to a test or from another source. In a furtherembodiment, as described previously, the electrophoresis strip 822 canhave a portion of the buffer applied in dry state, such as during amanufacturing process, that can be hydrated by the addition of adilutent, such as deionized water, prior to the electrophoresis processto wet the electrophoresis strip 822 in a buffer solution.

The blood sample, treated or untreated, can be transferred from thesample chamber 810 and a measured portion can be deposited onto theelectrophoresis strip 822 in a controlled manner at an initial position830. Once the blood sample has been deposited on the electrophoresisstrip 822, a voltage can be applied to or across the electrophoresisstrip 822 using the electrodes 824 and 826. One electrode is positivelycharged and the other is negatively charged, creating a voltage andcausing current to flow between the two electrodes 824, 826. The voltageor current between the electrodes 824, 826 causes portions of thedeposited blood sample to move across the electrophoresis strip 822 atvarying rates due to physical, electrical or chemical properties of eachof the portions. The voltage or current is applied at a set or varyingrate for a set amount of time to complete the test.

As shown in FIG. 8 , the blood sample has separated into 4 distinctbands 832, 834, 836 and 838. Each band corresponds to a particularcompound or component of the blood sample and the compounds orcomponents can be identified based on their movement along theelectrophoresis strip 822. Additionally, markers 840 a and 840 b wereincluded in the deposited blood sample to assist with the band analysisor evaluation. In the example shown, marker 840 a is positioned betweenbands 832 and 834. The positioning of marker 840 a between the two bands832, 834 can assist with differentiating each of the bands 832, 834during analysis or evaluation of the band data. The other marker 840 bis shown positioned with band 838. Marker 840 b was selected to have thesame electrophoresis properties as the compound or component associatedwith band 838, such that the marker 840 b and band 838 would progressalong the electrophoresis strip 822 together. Marker 840 b can assistwith determining the location of the band 838 and the distance the bandhas moved from the initial point 830. Markers can be selected based ontheir movement along the electrophoresis strip relative to the one ormore compounds or components of the blood sample. In an embodiment, themarkers can be selected to move with the one or more components orcompounds of the blood sample, move separate from the one or morecomponents or compounds of the blood sample (i.e., move at a differentrate), or a combination thereof. While the bands are shown as distinctlines in the example of FIG. 8 , in actuality each band will have awidth and often decreasing intensity along that width, much like thetail of a brushstroke.

An optical imaging device 850 can image the electrophoresis strip 822along with the bands 832, 834, 836, 838 and markers 840 a, 840 b presentalong its length. Using the captured image data, the optical imagingdevice, or another system or device such as a reader, can analyze theimage to identify the compounds or components associated with each ofthe bands 832, 834, 836, 838 and their relative proportions. Thecaptured image data can be used to determine a location of each of thebands 832, 834, 836, 838 and an intensity associated with each band. Theintensity of the band can be calculated from the image data or can bedetermined using alternative methods, such as measuring a lighttransmission through the electrophoresis strip 822 and bands 832, 834,836, 838 thereon. By plotting the intensity and position information,the proportion of each of the compounds or components represented by thebands 832, 834, 836, 838 can be determined by determining an area underthe curve for each of the bands 832, 834, 836, 838 represented on theplot.

To assist with accurate analysis of the blood sample, a known samplequantity can be collected or used for analysis using an electrophoresisanalysis process. The electrophoresis results indicate a relativeproportion of one or more components or compounds present within thesample. Using the known sample quantity and the proportions, the actualamounts, or estimates thereof, of each of the one or more components orcompounds present within the patient sample can be determined.

Imaging of the electrophoresis strip 822 and the bands and markersthereon can be performed using a set or varying spectrum of light oroptical imaging devices and techniques, to capture a variety ofinformation for use in analysis of the bands. In various lightingconditions and spectrums, different aspects of the bands can be moreeasily ascertained, such as band position and intensity. Additionally,the markers can be selected to fluoresce in certain lighting conditions,making it easier to determine a position of a marker relative to a bandon the electrophoresis strip 822. Multiple captured images can becomposited or used for the analysis process to increase theeffectiveness or accuracy of the band analysis or evaluation.

In an alternative embodiment, the imaging of the electrophoresis strip822 and the bands thereon can be performed using a generic opticalimaging device, such as a digital camera. The cartridge 800 can beimaged using the digital camera, such as by a cell phone camera, and thecaptured image can be transferred to a device or system for analysis orevaluation. Such functionality can also be a secondary analysis orevaluation, or verification, method to support the optical imagingmodule or device of a reader.

The optical imaging device 850 can acquire a set of images or video atan adjustable frame rate, or frames per second (FPS). In one example,the frame rate can be 1 FPS. In another example, the frame rate can begreater than 1 FPS, including at least 10 FPS, 24 FPS, 30 FPS, 120 FPS,240 FPS, 1000 FPS, 5000 FPS, 10000 FPS, or the like.

The optical imaging device 850 can capture images or video with highdynamic range (HDR) to provide enhanced image or video quality. Theimages or video can be taken at various exposures, at different f-stops,at different wavelengths, the like, or combinations or multiplesthereof. In one example, a first image can be captured where an emissionfrom the sample is at 415 nm and a second image can be captured where anemission from the sample is at 525 nm. The different wavelengths can beacquired across different images by using one or more filters, one ormore light sources, the like, or combinations or multiples thereof. Asanother example, the settings of the optical imaging device 850 can beadjusted between images or over the duration of the video.

FIG. 9 illustrates an example diagnostic system 900 that includes acartridge 910 and reader 920, such as described herein, the readerconnected 940 to an external device 930, such as a computing device,including a laptop, phone, tablet, a server, remote computer, or otherexternal device. The connection 940 between the reader 920 and theexternal device 930 can be a physical connection, such as a universalserial bus (USB) connector, such as shown in FIG. 9 , or can be awireless connection, such as an IR, Bluetooth® or WiFi electricalcoupling, or a combination thereof. The connection 940 allowscommunication between the reader 920 and the external device 930. In anexample, the reader 920 can perform analysis of a patient samplecontained within the cartridge 910, data from the various analysissystems or elements of the reader 920 can be transmitted through theconnection 940 to the external device 930 for processing. The externaldevice 930 can then display or transmit the processed results, orportion thereof, to a user or can optionally transmit the processedresults back to the reader 920 for display or transmission of theanalysis results, or a portion thereof, to the user. In a furtherexample, the reader 920 and external device 930 can both process all ora portion of the patient sample analysis data. The external device 930can also control one or more aspects of the reader 920, such as theanalysis able to be performed by the reader 920, authorized users of thereader 920 or other aspects of the reader 920 and its performance.Additionally, the external device 930 can be in the proximity of thereader 920, such as nearby, or can be remote from the reader 920, suchas in another room or in another location including in another country.The external device 930 can communicate with or be connected to multiplereaders and or other external systems, such as remote servers ordatabases.

FIG. 10 is an example reader network 1000. Various reader devices 1002a, 1002 b, 1002 c . . . 1002 n are connected to external devices orsystems, such as a server 1020 or computing device 1030, by a network1010. The readers 1002 a, 1002 b, 1002 c . . . 1002 n can send orreceive data, instructions, and other information to or from theexternal devices or systems 1020, 1030. The network 1010 can includephysical or electronic connections to facilitate communication from thereaders 1002 a, 1002 b, 1002 c . . . 1002 n to the external devices orsystems 1020, 1030.

The readers 1002 a, 1002 b, 1002 c . . . 1002 n can be readers for usewith a cartridge, as previously discussed, or can include otherdiagnostic or patient sample processing or storage devices. The readers1002 a, 1002 b, 1002 c . . . 1002 n can communicate with the externaldevices or systems 1020, 1030 to transmit analysis data, receiveanalysis results or information, transmit status information, receiveinstructions, receive software updates or other communications orinformation exchanged between one or more readers 1002 a, 1002 b, 1002 c. . . 1002 n or external devices or systems 1020, 1030. The readers 1002a, 1002 b, 1002 c . . . 1002 n can include a communication module toconnect the reader 1002 a, 1002 b, 1002 c . . . 1002 n to the network1010. The communication module can also be an external device to whichthe reader 1002 a, 1002 b, 1002 c . . . 1002 n is connected.

Additionally, the readers 1002 a, 1002 b, 1002 c . . . 1002 n cancommunicate with one another directly through a physical or wirelesselectronic connection. The connection between readers 1002 a, 1002 b,1002 c . . . 1002 n can include intervening network devices, such as arouter, or can be direct from one reader to one or more readers, such asan ad-hoc or local network. A reader can be designated as a primarydevice to transmit instructions to and receive data from other readersdesignated as secondary. Alternatively, no priority can be establishedbetween the readers 1002 a, 1002 b, 1002 c . . . 1002 n. The readers1002 a, 1002 b, 1002 c . . . 1002 n can perform the same or differentpatient sample analyses.

The network 1010 can include wired connections, such as through anEthernet connection, fiber optic connection, or other physical cable orconnection. The network 1010 can also include electronic communicationprotocols, systems or methods, such a satellite communication, microwavecommunication, Wi-Fi, and Bluetooth®. The network 1010 can includemultiple communication devices or protocols to facilitate communicationbetween one or more readers 1002 a, 1002 b, 1002 c . . . 1002 n orexternal devices or systems 1020, 1030.

An example external device or system can include one or more servers1020 which can be remote from or local to the readers 1002 a, 1002 b,1002 c . . . 1002 n. The server 1020 can include sample processing 1022,medical records 1024, reader control or modification 1026 or otherinformation or systems to communicate with or receive information from areader 1002 a, 1002 b, 1002 c . . . 1002 n.

Sample processing 1022 can include receiving data from a reader 1002 a,1002 b, 1002 c . . . 1002 n and analyzing the data to perform theanalysis of the patient sample. Remote processing of the patient sampledata can reduce the computing burden of the reader 1002 a, 1002 b, 1002c . . . 1002 n. Additionally, remote processing can allow for moreeffective and efficient processing by consolidating the analysis in oneor more locations, such as the server 1020. Consolidation can allow forthe use of computer learning or larger databases for use in analysis ofthe patient sample. Such data aggregation can be used to map or researchtrends, map the progression of disorders or various other data analyses.Additionally, updating the analysis process can be required at fewerlocations, the server 1020, rather than on each individual reader 1002a, 1002 b, 1002 c . . . 1002 n.

The server 1020 can also include medical records 1024. The analysisperformed by the server 1020 or reader 1002 a, 1002 b, 1002 c . . . 1002n can be appended to the relevant patient medical record 1024. Medicalrecords 1024 can be stored on the server 1020 or on an external deviceor system, to which the server 1020 or reader 1002 a, 1002 b, 1002 c . .. 1002 n can communicate the necessary data or analysis. The sampleprocessing 1022 can also access the medical records 1024 to performpattern analysis to determine trends, clusters, and potentialpreventative measures to reduce impact of a disease or condition in acertain region, population or demographic. Further, the pattern analysiscan be used to determine spread of a disease or migration of acondition.

The server 1020 can also include reader control or modification 1026.Reader control or modification 1026 can include reader calibrationinformation, software updates to the reader 1002 a, 1002 b, 1002 c . . .1002 n, ensuring proper or authorized use of a reader 1002 a, 1002 b,1002 c . . . 1002 n or other control or operational changes to a reader1002 a, 1002 b, 1002 c . . . 1002 n. Centralizing reader control ormodification 1026 can assist with proper reader 1002 a, 1002 b, 1002 c .. . 1002 n usage, maintenance or functionality to provide efficient andeffective patient sample analysis using a reader 1002 a, 1002 b, 1002 c. . . 1002 n.

Another example external device or system can include one or morecomputing devices 1030. The computing device 1030, such as a mobilephone, computer, tablet, or other device, can be connected to one ormore readers 1002 a, 1002 b, 1002 c . . . 1002 n through the network1010. The computing device 1030 can receive information from the reader1002 a, 1002 b, 1002 c . . . 1002 n and perform some or all the sampleprocessing or analysis 1032, based on the received information.Additionally, the external device 1030 can act as an output to which thereader 1002 a, 1002 b, 1002 c . . . 1002 n transmits results, data orinformation regarding the patient sample analysis. As with the server,discussed above, the computing device 1030 can also include readercontrol or modification 1034. The reader control or modification 1034can provide an input through which instruction to a reader 1002 a, 1002b, 1002 c . . . 1002 n can be entered. Additionally, the reader controlor modification 1034 can include calibration or maintenance data orprocesses a user or reader 1002 a, 1002 b, 1002 c . . . 1002 n canperform to assist with maintenance or calibration of the reader 1002 a,1002 b, 1002 c . . . 1002 n. The proper functioning and calibration ofthe reader 1002 a, 1002 b, 1002 c . . . 1002 n can assist with theefficient and effective analysis of patient samples. Additionally, thecomputing device 1030 can communicate with the server 1020 using thenetwork 1010 or other communication means, systems or processes.

In an example, the computing device 1030 can store or transmit data fromone or more readers 1002 a, 1002 b, 1002 c . . . 1002 n to the server1020. The data transmission can be in real-time or can be stored andtransmitted when convenient or the computing device 1030 is againconnected to a network 1010. Additionally, the computing device 1030 cantransmit the results of an analysis to a patient or a patientrepresentative, such as a patient's physician. As with transmission ofthe data from the reader, the transmission of the patient analysis canbe performed in real-time or at a later time, such as when the computingdevice 1030 is again connected to a network 1010.

One of the functions of the reader network 1000 can include the sharingof the unique cartridge identifications of each of the cartridgesanalyzed by the readers 1002 a, 1002 b 1002 c . . . 1002 n of thenetwork 1000. Sharing the identification of each of the previously usedcartridges can prevent the unauthorized reuse of a cartridge. Eachreader 1002 a, 1002 b 1002 c . . . 1002 n can query the server 1020,computing device 1030 or other readers to determine if a cartridge hasbeen previously used as part of a cartridge verification process. In anembodiment, a list of cartridge identifications associated withpreviously used cartridges can be provided regularly to the reader 1002a, 1002 b 1002 c . . . 1002 n, such as by the server 1020 or computingdevice 1030 via the network 1010, to update the cartridge verificationsystem of the reader 1002 a, 1002 b 1002 c . . . 1002 n to prevent reuseof cartridges. Alternatively, or additionally, a list of cartridgeidentifications associated with unused cartridges can be providedregularly to the reader 1002 a, 1002 b 1002 c . . . 1002 n to assistwith cartridge verification.

Any list or options presented in an alternative form, such as “or,” isnot intended to be limited just one of the list components. The “or” isintended to include “the like, or combinations of multiples thereof,”thereby permitting for additional or alternative components,combinations of components, or a plurality of one or more components.

The foregoing description, for purposes of explanation, used specificnomenclature to provide a thorough understanding of the disclosure.However, it will be apparent to one skilled in the art that the specificdetails are not required in order to practice the systems and methodsdescribed herein. The foregoing descriptions of specific embodiments arepresented by way of examples for purposes of illustration anddescription. They are not intended to be exhaustive of or to limit thisdisclosure to the precise forms described. Many modifications andvariations are possible in view of the above teachings. The embodimentsare shown and described in order to best explain the principles of thisdisclosure and practical applications, to thereby enable others skilledin the art to best utilize this disclosure and various embodiments withvarious modifications as are suited to the particular use contemplated.It is intended that the scope of this disclosure be defined by thefollowing claims and their equivalents.

What is claimed is:
 1. An electrophoresis detection system, comprising:an illumination source configured to: during an assay run on anelectrophoresis strip, emit a first stimulus having a first wavelength,during the assay run on the electrophoresis strip, emit a secondstimulus having a second wavelength, and processing circuitry programmedto: generate an instruction to cause the illumination source to emit thefirst stimulus and the second stimulus; receive multiple optical imagesof the electrophoresis strip, each of the multiple images capturedduring the assay run, including a first image captured at a first timepoint during the assay run when the first stimulus is emitted and asecond image captured at a second time point during the assay run whenthe second stimulus is emitted; during the assay run, detect banddetection data based on the multiple optical images of theelectrophoresis strip, the band detection data having: a first detectioncharacteristic generated from the first image, the first detectioncharacteristic of the first image detected in response to emission ofthe first stimulus and including band thickness and band speed of both afirst band and a second band, and a second detection characteristicgenerated from the second image, the second detection characteristic ofthe second image detected in response to emission of the second stimulusand including band thickness and band speed of both the first band andthe second band, during the assay run, identify a component associatedwith the band detection data based on the first characteristic and thesecond characteristic; and during the assay run, transmit an identifierof the component to an output.
 2. The electrophoresis detection systemof claim 1, wherein the first wavelength is different than the secondwavelength.
 3. The electrophoresis detection system of claim 2, whereinthe component has a peak absorption in the UV spectrum.
 4. Theelectrophoresis detection system of claim 2, wherein the firstwavelength is in an ultraviolet (UV) spectrum and the second wavelengthis in the visible spectrum.
 5. The electrophoresis detection system ofclaim 1, wherein the first wavelength or the second wavelength is withina range of 375-440 nm.
 6. The electrophoresis detection system of claim1, wherein the component is conjugated with multiple stains, a firststain of the multiple stains having a peak absorption at the firstwavelength or within a range that includes the first wavelength, and asecond stain of the multiple stains having a peak absorption at thesecond wavelength or within a range that includes the second wavelength.7. The electrophoresis detection system of claim 6, wherein thecomponent is a first component conjugated to the first stain, and theprocessing circuitry is further configured to identify the firstcomponent based on the first detection characteristic and the seconddetection characteristic of the first band associated with the banddetection data and to identify a second component that is conjugated tothe second stain, the second component identified based on the firstdetection characteristic and the second detection characteristic of thesecond band associated with the band detection data.
 8. Theelectrophoresis detection system of claim 7, further comprising: adetection module configured to, during the assay run, generate a signalrepresenting a combination of the first detection characteristic and thesecond detection characteristic of the first band of the band detectiondata and a signal representing the first detection characteristic andthe second detection characteristic of the second band of the banddetection data into a combined band detection signal, and the processingcircuitry is further configured to, during the assay run, identify thecomponent associated with the band detection data based on acharacteristic of the combined band detection signal.
 9. Theelectrophoresis detection system of claim 7, wherein the first detectioncharacteristic and the second detection characteristic include one orboth of: an emission by the first stain when excited by the firststimulus, and an emission by the second stain when excited by the secondstimulus.
 10. The electrophoresis detection system of claim 6, whereinat least one of the multiple stains is fluorescent.
 11. Theelectrophoresis detection system of claim 1, wherein the first detectioncharacteristic includes a detected emission value of the component inresponse to the first stimulus emitted at the first wavelength, and thesecond detection characteristic includes a detected emission value ofthe component in response to the second stimulus emitted at the secondwavelength.
 12. The electrophoresis detection system of claim 1, whereinthe first detection characteristic includes one or more of location,emission intensity, absorption intensity, relative comparison of aparameter of the band in the multiple optical images, or a relativecomparison of a parameter of the first band of the band detection datato the parameter of one or more other bands of the band detection datain the multiple optical images of the electrophoresis strip.
 13. Theelectrophoresis detection system of claim 12, wherein the seconddetection characteristic is one or more of location, emission intensity,absorption intensity, relative comparison of a parameter of the band inthe multiple optical images, or a relative comparison of a parameter ofthe first band to the parameter of one or more other bands in themultiple optical images of the electrophoresis strip.
 14. Theelectrophoresis detection system of claim 1, wherein the processingcircuitry is further configured to detect the band detection data fromthe first band and the second band on the electrophoresis strip in morethan one of the multiple optical images, and determine a position withrespect to time of each of the first band and the second band betweenthe more than one of the multiple optical images.
 15. Theelectrophoresis detection system of claim 1, further comprising anoptical detector configured to: during the assay run, capture the firstimage of the electrophoresis strip at the first time point and thesecond image of the electrophoresis strip at the second time point, andgenerate the band detection data based on the first image and the secondimage.
 16. The electrophoresis detection system of claim 15, wherein themultiple optical images received by the processing circuitry includes avideo of the electrophoresis strip over a time period, wherein the videois acquired during the assay run.
 17. The electrophoresis detectionsystem of claim 1, wherein the processing circuitry is furtherconfigured to output diagnostic results based on one or more of the banddetection data, the component, or the identifier.
 18. Theelectrophoresis detection system of claim 17, wherein one or both of theidentifier and the band detection data is transmitted to a remotecomputing device, network, or server.
 19. The electrophoresis detectionsystem of claim 1, wherein the component includes a type or variant ofhemoglobin.
 20. The electrophoresis detection system of claim 1, whereinthe component includes a protein.
 21. The electrophoresis detectionsystem of claim 1, wherein the processing circuitry is furtherconfigured to determine a quantification parameter of the band detectiondata, the quantification parameter including a quantity or relativequantity of the component.
 22. The electrophoresis detection system ofclaim 1, wherein the processing circuitry is further configured todetermine a qualification parameter of the band detection data.
 23. Theelectrophoresis detection system of claim 21, wherein the quantificationparameter of the band detection data further includes one or more ofposition or intensity of the band over time during a time period thatoccurs during the assay run.
 24. The electrophoresis detection system ofclaim 1, wherein the processing circuitry is further configured to,during the assay run, continuously transmit the multiple optical imagesto the output.
 25. The electrophoresis detection system of claim 1,wherein: the first detection characteristic of the first image includesa first light intensity value of a first band and a first lightintensity value of a second band, both the first band and the secondband associated with the band detection data, and the second detectioncharacteristic of the second image includes a second light intensityvalue of the first band and a second light intensity value of the secondband, and wherein the processing circuitry is further configured to,during the assay run, detect the band detection data based on: adifference or a relative change of the first detection characteristic,and a difference or a relative change of the second detectioncharacteristic.
 26. The electrophoresis detection system of claim 25,wherein the processing circuitry is further configured to, during theassay run, detect band detection data based on: the difference or arelative change of the first characteristic one or both of increasing ordecreasing during the assay run, and the difference or a relative changeof the second characteristic one or both of increasing or decreasingduring the assay run.
 27. The electrophoresis detection system of claim1, wherein: the first detection characteristic includes a characteristicof a first signal representing light intensity values across a bandwidth of the first band and a second signal representing light intensityvalues across a band width of the second band captured in the firstimage, and the second detection characteristic includes a characteristicof the first signal representing light intensity values across the bandwidth of the first band and the second signal representing lightintensity values across the band width of the second band captured inthe second image.
 28. The electrophoresis detection system of claim 27,wherein the characteristic of the first signal and the second signal inthe first detection characteristic and the second detectioncharacteristic, respectively, includes a waveform shape of the firstsignal and the second signal, respectively.
 29. The electrophoresisdetection system of claim 1, wherein the processing circuitry is furtherconfigured to compare the first detection characteristic and the seconddetection characteristic and, during the assay run, to identify thecomponent based on the comparison of the first detection characteristicand the second detection characteristic.
 30. The electrophoresisdetection system of claim 1, wherein the processing circuitry is furtherconfigured to determine an average of a feature of the first detectioncharacteristic and the second detection characteristic and, during theassay run, to identify the component based on the average of the firstdetection characteristic and the second detection characteristic. 31.The electrophoresis detection system of claim 1, wherein the secondimage includes a band of interest and the first image does not includethe band of interest.
 32. The electrophoresis detection system of claim1, wherein the processor is further configured to: determine aneffectiveness of the assay run based on the first detectioncharacteristic and the second detection characteristic of both the firstimage and the second image, and based on the determined effectiveness ofthe assay run, generate an instruction to stop, continue, or re-run theassay or to output an error message or suggested solution.